Regulation (EU) 2024/1689: Harmonised Rules on Artificial Intelligence
REGULATION (EU) 2024/1689 establishes a harmonized legal framework for artificial intelligence (AI) within the European Union, aiming to enhance the internal market while ensuring health, safety, and fundamental rights protection. The regulation promotes the development and use of trustworthy AI systems, preventing member states from imposing restrictive national rules that could fragment the market. It emphasizes the importance of aligning AI deployment with Union values, including democracy and environmental protection, while supporting innovation and employment. Specific provisions address the processing of personal data and the use of AI in law enforcement contexts.
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Article, Directive, Date
- Around Article, Directive, Date.
- 10 000 registered business users, 12.7, 12.7.2024, 2 August 2026, 2 August 2027, 2 August 2030, 2 August 2031, 2 February 2025, 31 December 2030, AI systems for remote biometric identification, Article 100, Article 15, Article 16, Article 22(1), Article 25, Article 30 of Regulation (EU) 2019/1020, Article 33 of Regulation (EU) 2019/1020, Article 34, Article 36, Article 43, Article 49(1), Article 5 TEU, Article 52, Article 56, Article 6, Article 63, Article 65, Article 66, Article 68(1), Article 69, Article 7, Article 73, Article 74(10), Article 74(11), Article 88, Article 89, Article 96, CE marking, Charter of Fundamental Rights of the European Union, Court of Justice of the European Union, Directive 2002/58/EC, Directive 2009/48/EC, Directive 2014/31/EU, Directive 2014/32/EU, Directive on privacy and electronic communications, ELI, ELI: http://data.europa.eu/eli/reg/2024/1689/oj, EU information systems, European Artificial Intelligence Board, European Union, Free and open-source AI components, M. Michel, Mutual recognition agreements, OJ L, OJ L, 12.7.2024, R. Metsola, Recommendation 2003/361/EC, Regulation, Regulation (EU) 2019/817, Regulation 2024/1689, UNCRC General Comment No 25 (2021), asylum authorities, border control authorities, cyber resilience, governance framework, immigration authorities, market, military purposes, models, open-source model, principle of subsidiarity, publicly accessible space, reg/2024/1689/oj, regulation 2024/1689, remote biometric identification system, scientific research and development
Technical documentation, Regulation, Institution
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- AI literacy, AI systems, Article 39 of the Charter, Directive 2013/32/EU, Regulation (EC) No 810/2009, Regulation (EU) 2024/900, UN Convention relating to the Status of Refugees, Union anti-money laundering law, Union harmonisation legislation, Union institutions, Union’s Ethics Guidelines for Trustworthy AI, affected persons, competent public authorities, critical thinking, cryptographic methods, education, effective remedy, election or referendum, extreme poverty, fair trial, fingerprints, health and safety, health sector, high-quality data, in vitro diagnostic medical devices, law enforcement authorities, learning outcomes, logging methods, machinery, manipulative or exploitative AI-enabled practices, media literacy, medical devices, metadata identifications, natural person, polygraphs, post-market monitoring plan, presumption of innocence, public security, risk analytics, significant harm, synthetic content, technical solutions, third-party conformity assessment body, toys, transparency, watermarks
Article, Regulation, Ai system
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- 10 years, AI, AI model, AI system, AI systems as safety components, Article 13(3), point (d), Article 27, Article 27 of Directive (EU) 2016/680, Article 35 of Regulation (EU) 2016/679, Article 49, Article 49(2), Article 49(3), Article 8, Article 9, Articles 40 and 41, Chapter III, Section 2, Charter, Council Directive 84/450/EEC, Council Framework Decision 2002/584/JHA, Critical digital infrastructure, Directive (EU) 2022/2557, Directive 2005/29/EC, European health data space, Regulation (EC) No 2006/2004, Treaties, Treaty on European Union (TEU), Union or national law, Union technical documentation assessment certificate, Union values, administrative fine, civilian purposes, critical infrastructure, cybersecurity, data governance, data sheets, deep fakes, distributor, facial recognition databases, free and open-source licence, fundamental rights, importer, logic- and knowledge-based approaches, machine learning approaches, model cards, operator, quality data, real-time remote biometric identification systems, safety components, social scoring, substantial modification, training data, transparency obligation, validation and testing procedures, validation data, vulnerable position
Regulation, Article, Ai system
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- 18 June 2021, 2024/1689, AI ecosystem, AI regulatory sandbox, AI systems for detecting financial fraud, AI systems for emergency call evaluation, AI systems for risk assessment and pricing, AI systems intended for biometric categorisation, AI systems intended for biometric verification, Annex II, Article 10, Article 10 of Directive (EU) 2016/680, Article 10(1), Article 114 TFEU, Article 13, Article 13 of Directive (EU) 2016/680, Article 16 TFEU, Article 3, point (4), Article 3, point (5), Article 35, Article 4 (1) of Directive (EU) 2016/680, Article 4, point (4), Article 59, Article 62(1), point (c), Article 9(1), Council Framework Decision 2008/977/JHA, Data Act, Data Governance Act, Decision No 768/2008/EC, Directive (EU) 2016/680, European Data Protection Board, European Data Protection Supervisor, European Digital Innovation Hubs, Law enforcement authorities, Market surveillance authorities, Regulation (EC) No 765/2008, Regulation (EU) 2016/679, Regulation (EU) 2016/680, Regulation (EU) 2018/1725, Regulation (EU) 2022/868, Regulation (EU) 2023/2854, Regulation on the ‘real-time’ use of AI systems, Regulations (EU) 2016/679, Regulations (EU) 2018/1725, Remote biometric identification systems, TFEU, Union data protection law, Union institution, body, office or agency, Union institutions, agencies and bodies, Union law on the protection of personal data, biometric categorisation system, biometric data, common rules for AI regulatory sandboxes, data sets, deep fake, drivers, emotion recognition system, high-risk AI system for post-remote biometric identification, innovative AI systems, law enforcement, microenterprises, national accreditation body, personal data, post-remote biometric identification system, post-remote biometric identification systems, professional pilots, real-time systems, sandbox, sandbox plan, widespread infringement
Article, Technical documentation, Ai system
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- AI Regulatory Sandbox, AI System, Annex IX, Article 57, Article 60, Biometrics, Critical infrastructure, Data and data governance, Deployer, Directive (EU) 2016/943, Education and vocational training, Hardware, High-risk AI system, High-risk AI systems, Importers and distributors, Instructions for use, Market Surveillance Authorities, Market Surveillance Authority, Provider, Public authorities, Section 3, Software Packages, Technical Documentation, Union and National Liability Law, User Interface, common specifications, conformity assessment procedure, critical products, cybersecurity measures, feedback loops, logs, performance metrics, technical redundancy solutions, testing in real-world conditions, training, validation and testing data sets
Ai system, Directive, Institution
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- 17 April 2019, AI systems for credit evaluation, AI systems for health and life insurance, AI-enabled manipulative techniques, Council Directive 85/374/EEC, Council of the European Union, Directive (EU) 2019/790, Directive (EU) 2019/882, Directives 96/9/EC and 2001/29/EC, Emergency response AI systems, European Parliament, New Legislative Framework, The 'Blue Guide' on the implementation of EU product rules 2022, Union law, data collected, ethnic or religious minorities, machine-brain interfaces, persons living in extreme poverty, virtual reality
Personal data, Institution, Computation
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- AI systems for creditworthiness evaluation, AI systems for public services evaluation, AI systems for recruitment, AI systems for risk assessment in insurance, AI systems for social scoring, AI systems for work-related decisions, Article 5(1), Article 50, Ireland, Protocol No 21, Union and national law, biometric categorisation systems, biometric identification systems, credit score evaluation, discriminatory outcomes, imminent threat to life, natural persons, public assistance benefits, remote biometric identification
User, Ai system, Computation
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- 1025, Annex XI, Annex XII, Annex XIII, Article 101, Article 4, Article 53(1), point (b), Article 91, Article 93, European Artificial Intelligence Office, European harmonised standards, Union copyright law, acceptable use policies, computational resources, copyright protected content, criteria for designation, cybersecurity protection, data, data collections, data used for training, date of release, downstream provider, energy consumption, evaluation strategies, fine-tuning, floating point operations, general-purpose AI model, general-purpose AI models, general-purpose AI system, high impact capabilities, high-impact capabilities, internal and/or external adversarial testing, internal processes, modality, model evaluations, open-source license, parameters, pre-training, providers of general-purpose AI models with systemic risk, reinforcement learning, rightsholders, risk taxonomy, risk-management policies, self-supervised learning, synthetic data generation, system architecture, systemic risk, systemic risks, text and data mining, threshold of floating point operations, training data set, training data sources, unsupervised learning
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- AI value chain, Article 10(4), Article 18, Article 26, Article 31, Article 32, Article 33, Article 47, Article 71(4), Commission Work Programme 2021, Directive 2001/83/EC, Directive 2006/42/EC, Directive 98/79/EC, EU declaration of conformity, European Parliament and Council Regulation, Fundamental rights impact assessment, General-purpose AI systems, OJ L 117, 5.5.2017, Regulation (EC) No 1223/2009, Regulation (EC) No 178/2002, Regulation (EU) 2017/745, Regulation (EU) 2017/746, Union legal framework, accreditation certificate, alternative dispute resolution bodies, asylum, automation bias, border control management, certificates, confidential business information, conformity assessment, conformity assessment body, deployers, digital CE marking, ethical and trustworthy AI, fundamental rights impact assessment, high-risk AI systems, human oversight, intellectual property rights, internal market, migration, model evaluation, model retraining, model testing, model training, national competent authorities, notified bodies, notifying authority, post-market monitoring system, product manufacturer, public interests, real-world testing plan, right not to be discriminated against, right to education and training, risk management system, technical robustness, third party, trade secrets, transparency requirements, users
Institution, Regulation, Article
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- Article 54(3), CEN, CENELEC, ENISA, ETSI, Fundamental Rights Agency, Regulation (EU) 2019/881, Regulation (EU) No 526/2013, advisory forum, cybersecurity scheme
Article, Institution, Regulation
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- Advisory Forum, Article 18 of Regulation (EU) 2019/1020, Article 20, Article 21, Article 3, Article 30, Article 34(4), Article 74, Article 76, Article 79, Article 85, Article 86, Article 94, Board, Chapter VI of Regulation (EU) 2019/1020, Council Regulation (EU) No 1024/2013, Directive 2002/87/EC, Directive 2009/138/EC, Directive 2013/36/EU, Directive on improving working conditions in platform work, Directives 2006/48/EC and 2006/49/EC, European Central Bank, National authorities, Regulation (EU) 2019/1020, Regulation (EU) No 1024/2013, Union bodies, Union market, authorised representative, competent authority, distributors, mandate, market surveillance authorities, prohibited systems, providers of general-purpose AI models, providers of high-risk AI systems, surveillance authorities
Directive, Regulation, Article
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- 13 June 2024, Article 102, Article 103, Article 104, Article 77(1), Article 87, Artificial Intelligence Act, Council Directive 87/357/EEC, Council of 25 November 2020, Directive (EU) 2016/797, Directive (EU) 2019/1937, Directive (EU) 2020/1828, Directive 2001/95/EC, Directive 2009/22/EC, Directive 2014/90/EU, Directives 2014/31/EU, Directives 2014/32/EU, Directives 2014/90/EU, 2016/797, 2020/1828, European Parliament and Council, European Parliament and of the Council, OJ L 60, 2.3.2013, OJ L 97, 9.4.2008, Regulation (EC) No 2320/2002, Regulation (EC) No 300/2008, Regulation (EU) 2018/1139, Regulation (EU) 2018/858, Regulation (EU) 2019/2144, Regulation (EU) 2023/988, Regulation (EU) 2024/1689, Regulation (EU) No 167/2013, Regulation (EU) No 168/2013, Union Law, international organisations, persons who report breaches
Institution, Article, Technical documentation
- Around Institution, Article, Technical documentation.
- 2019 Ethics Guidelines for Trustworthy AI, AI HLEG, AI Regulation, AI Systems, AI practices, Accreditation Certificate, Annex I, Article 14, Article 19, Article 77, Article 78, Article 80, Articles 79 to 83, Certificates, Conformity Assessment, Conformity Assessment Bodies, Ethics guidelines for trustworthy AI, European Standardisation Organisations, High-Risk AI Systems, Member State, Notified Bodies, Notifying Authorities, Union Harmonisation Legislation, Union safeguard procedure, exit report, independent administrative authority, judicial authority, law enforcement authority, law-enforcement authorities, market surveillance authority, national data protection authority, national law, national public authorities, national public authorities or bodies, natural and legal persons, notification template, paragraph 1, first subparagraph, point (h), paragraph 5, product manufacturers, real-time biometric identification systems, real-time remote biometric identification system, reference database of persons, specific high-risk AI systems, testing in real world conditions, urgent situations, vulnerable groups
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- Around Article, Technical documentation, Institution.
- 15 days, AI project, Annex IV, Annex VI, Annex VII, Article 12, Article 12(1), Article 17, Article 24, Article 26(5), Article 29(2), Article 29(3), Article 37, Article 45, Article 48, Article 53(1), Article 6(3), Article 72, Article 79(1), Article 9(2), Articles 29 and 30, Conformity assessment procedure based on internal control, Directive (EU) 2016/2102, Quality management system, Section A of Annex I, Union harmonised legislation, Union institutions, bodies, offices or agencies, Union technical documentation assessment certificates, United Nations Convention on the Rights of Persons with Disabilities, accountability framework, audit report, civil society organisations, competent authorities, conformity assessment procedures, data management systems, deployer, discrimination, fundamental rights impact assessments, high-risk AI system, impact assessment, national competent authority, notified body, provider, providers concerned, public sector bodies, quality management system, quality management system approvals, risk assessment, risk-management system, safeguards, sectoral group of notified bodies, sensitive operational data, serious incident, technical documentation, technical limitations, testing data sets, training data sets, validation data sets
Article, Regulation, Directive
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- AI models, Article 11, Article 16(1), Article 16(6), Article 2, point (1)(c), Article 40, Article 41, Article 51, Benchmarks, Chapter V, Computation, Council Directives 89/686/EEC and 93/15/EEC, Data set, Digital Services Act, Directive 2000/31/EC, Directive 2008/48/EC, European standardisation organisations, General-purpose AI models, Internal market, Modalities, Official Journal of the European Union, Parameters, Registered business users, Registered end-users, Regulation (EU) 2022/2065, Regulation (EU) No 1025/2012, Regulation (EU) No 575/2013, Section 2, Union financial services law, biometric categorisation, common specification, compliance, deployers of high-risk AI systems, fundamental rights concerns, harmonised standard, harmonised standards, intermediary services, providers that are financial institutions, public interest, very large online platforms, very large online search engines
Article, Institution, Technical documentation
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- 2 August 2028, 2 August 2029, 2 February 2026, 7 %, Annex III, Annex V, Annex VIII, Annexes VI and VII, Article 112, Article 22, Article 28, Article 49(4), Article 49(5), Article 5, Article 56 (6), Article 67, Article 71, Article 97, Article 97(2), Article 98, Article 99, Commission, Council, EU Database, EU database, EU database for high-risk AI systems, EUR 1 500 000, EUR 35 000 000, EUR 750 000, European Economic and Social Committee, Interinstitutional Agreement of 13 April 2016, National Data Protection Authority, Prohibited AI practices, Regulation (EU) No 182/2011, World Trade Organization Agreement on Technical Barriers to Trade, annual reports, benchmarks, electronic notification tool, environmental sustainability, general-purpose AI systems, international partners, knowledge and best practices, list of general-purpose AI models, metrology and benchmarking authorities, mutual recognition agreements, national authorities, notifying authorities, providers, public authorities, regulation, small and microenterprises, standing subgroup for market surveillance
Ai system, Date, Regulation
Ai system, Date, Regulation
Article, Institution, Regulation
- Around Article, Institution, Regulation.
- 15 calendar days, 2 August 2025, 2 May 2025, 2017/746, AI Office, AI regulatory sandboxes, AI-on-demand platform, Article 290 TFEU, Article 4(2) TEU, Article 53, Article 54, Article 55, Article 58, Article 61, Article 62, Article 64, Article 68, Article 70, Article 83, Article 84, Article 90, Article 92, Article 98(2), Articles 53 and 55, Articles 91 to 94, Artificial Intelligence systems, Chapter 2 of Title V TEU, Commission Decision of 24 January 2024, Commission Decision of 24.1.2024, Commission Recommendation 2003/361/EC, Digital Europe Programme, Digital Single Market, EuroHPC Joint Undertaking, European Commission, Europol, Horizon Europe, Interinstitutional Agreement of 13 April 2016 on Better Law-Making, Member States, National competent authorities, SMEs, Scientific Panel, Union, Union ethical guidelines for trustworthy AI, Union-wide unique single identification number, accuracy, codes of conduct, codes of practice, ethical principles, general-purpose AI models with systemic risk, implementation acts, implementing act, inclusive and diverse design, independent experts, informed consent, joint investigations, key performance indicators, provider or prospective provider, public authorities or bodies, robustness, scientific community, scientific panel, stakeholders, standardisation development processes, start-ups, subject, testing and experimentation facilities, third country, this Regulation, vulnerable persons
Content
Show original text
REGULATION (EU) 2024/1689 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 13 June 2024
laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008,
(EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and
Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act)
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 16 and 114 thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
Having regard to the opinion of the European Central Bank (2),
Having regard to the opinion of the Committee of the Regions (3),
Acting in accordance with the ordinary legislative procedure (4),
Whereas:
(1)
The purpose of this Regulation is to improve the functioning of the internal market by laying down a uniform legal
framework in particular for the development, the placing on the market, the putting into service and the use of
artificial intelligence systems (AI systems) in the Union, in accordance with Union values, to promote the uptake of
human centric and trustworthy artificial intelligence (AI) while ensuring a high level of protection of health, safety,
fundamental rights as enshrined in the Charter of Fundamental Rights of the European Union (the ‘Charter’),
including democracy, the rule of law
Show original text
This
regulation aims to ensure that artificial intelligence (
AI) is developed and used safely while protecting health, safety,
fundamental rights, democracy, the rule of law, and the environment, as outlined in the
Charter of Fundamental Rights of the European Union. It also supports innovation. The
regulation allows for the free movement of
AI-based goods and services across borders, preventing EU
member states from imposing restrictions on
AI systems unless specifically allowed by this
regulation.
The
regulation should align with the values of the
Union as stated in the
Charter, promoting the protection of individuals, businesses, democracy, the rule of law, and
environmental sustainability, while also encouraging innovation and job creation. This will help the EU become a leader in trustworthy
AI.
AI systems can be used in many sectors and can easily move across the EU. Some
member states have started to create their own rules to ensure
AI is safe and respects
fundamental rights. However, differing national regulations could disrupt the
internal market and create uncertainty for those developing, importing, or using
AI systems. Therefore, it is essential to maintain a consistent and high level of protection across the EU to ensure trustworthy
AI and prevent obstacles to the free movement, innovation, and deployment of
AI systems and related products and services.
artificial intelligence (AI) while ensuring a high level of protection of health, safety,
fundamental rights as enshrined in the Charter of Fundamental Rights of the European Union (the ‘Charter’),
including democracy, the rule of law and environmental protection, to protect against the harmful effects of AI
systems in the Union, and to support innovation. This Regulation ensures the free movement, cross-border, of
AI-based goods and services, thus preventing Member States from imposing restrictions on the development,
marketing and use of AI systems, unless explicitly authorised by this Regulation.
(2)
This Regulation should be applied in accordance with the values of the Union enshrined as in the Charter, facilitating
the protection of natural persons, undertakings, democracy, the rule of law and environmental protection, while
boosting innovation and employment and making the Union a leader in the uptake of trustworthy AI.
(3)
AI systems can be easily deployed in a large variety of sectors of the economy and many parts of society, including
across borders, and can easily circulate throughout the Union. Certain Member States have already explored the
adoption of national rules to ensure that AI is trustworthy and safe and is developed and used in accordance with
fundamental rights obligations. Diverging national rules may lead to the fragmentation of the internal market and
may decrease legal certainty for operators that develop, import or use AI systems. A consistent and high level of
protection throughout the Union should therefore be ensured in order to achieve trustworthy AI, while divergences
hampering the free circulation, innovation, deployment and the uptake of AI systems and related products and
services within the internal market should be prevented by laying down uniform obligations for operators and
Official Journal
of the European Union
EN
L series
2024/1689
12.7.
Show original text
the uptake of AI systems and related products and
services within the internal market should be prevented by laying down uniform obligations for operators and
Official Journal
of the European Union
EN
L series
2024/1689
12.7.2024
ELI: http://data.europa.eu/eli/reg/2024/1689/oj
1/144
(1)
OJ C 517, 22.12.2021, p. 56.
(2)
OJ C 115, 11.3.2022, p. 5.
(3)
OJ C 97, 28.2.2022, p. 60.
(4)
Position of the European Parliament of 13 March 2024 (not yet published in the Official Journal) and decision of the Council of
21 May 2024.
guaranteeing the uniform protection of overriding reasons of public interest and of rights of persons throughout the
internal market on the basis of Article 114 of the Treaty on the Functioning of the European Union (TFEU). To the
extent that this Regulation contains specific rules on the protection of individuals with regard to the processing of
personal data concerning restrictions of the use of AI systems for remote biometric identification for the purpose of
law enforcement, of the use of AI systems for risk assessments of natural persons for the purpose of law
enforcement and of the use of AI systems of biometric categorisation for the purpose of law enforcement, it is
appropriate to base this Regulation, in so far as those specific rules are concerned, on Article 16 TFEU. In light of
those specific rules and the recourse to Article 16 TFEU, it is appropriate to consult the European Data Protection
Board.
Show original text
Regulation related to specific rules under
Article 16 TFEU requires consultation with the
European Data Protection Board.
AI is a rapidly developing technology that offers numerous economic, environmental, and social benefits across various industries. It enhances predictions, optimizes operations, and personalizes digital solutions, providing competitive advantages and supporting positive outcomes in areas like healthcare, agriculture, education, media, energy, and environmental conservation. However, depending on how it is used and its level of development,
AI can also pose risks and harm public interests and
fundamental rights protected by EU law, which may include physical, psychological, social, or economic harm. Given
AI's significant societal impact, it is essential that its development aligns with EU values,
fundamental rights, and the
Charter, as stated in Article 2 and
Article 6 of the Treaty on
European Union.
AI should prioritize human needs and aim to enhance human well-being.
Regulation, in so far as those specific rules are concerned, on Article 16 TFEU. In light of
those specific rules and the recourse to Article 16 TFEU, it is appropriate to consult the European Data Protection
Board.
(4)
AI is a fast evolving family of technologies that contributes to a wide array of economic, environmental and societal
benefits across the entire spectrum of industries and social activities. By improving prediction, optimising operations
and resource allocation, and personalising digital solutions available for individuals and organisations, the use of AI
can provide key competitive advantages to undertakings and support socially and environmentally beneficial
outcomes, for example in healthcare, agriculture, food safety, education and training, media, sports, culture,
infrastructure management, energy, transport and logistics, public services, security, justice, resource and energy
efficiency, environmental monitoring, the conservation and restoration of biodiversity and ecosystems and climate
change mitigation and adaptation.
(5)
At the same time, depending on the circumstances regarding its specific application, use, and level of technological
development, AI may generate risks and cause harm to public interests and fundamental rights that are protected by
Union law. Such harm might be material or immaterial, including physical, psychological, societal or economic
harm.
(6)
Given the major impact that AI can have on society and the need to build trust, it is vital for AI and its regulatory
framework to be developed in accordance with Union values as enshrined in Article 2 of the Treaty on European
Union (TEU), the fundamental rights and freedoms enshrined in the Treaties and, pursuant to Article 6 TEU, the
Charter. As a prerequisite, AI should be a human-centric technology. It should serve as a tool for people, with the
ultimate aim of increasing human well-being.
Show original text
According to the
Treaties and
Article 6 of the Treaty on
European Union (
TEU),
AI should prioritize human needs and aim to enhance people's well-being. To protect public interests related to health, safety, and
fundamental rights, we need to establish common rules for
high-risk AI systems. These rules must align with the
Charter, be non-discriminatory, and comply with the EU's international trade
obligations. They should also consider the European Declaration on Digital Rights and Principles for the Digital Decade, as well as the
Ethics guidelines for trustworthy AI from the High-Level Expert Group on Artificial Intelligence (
AI HLEG).
To support the development and use of
AI in the
internal market while ensuring high protection for public interests like health, safety, and
fundamental rights—including democracy, the rule of law, and environmental protection—there needs to be a unified legal framework for
AI. This framework should regulate the market entry, operation, and use of certain
AI systems, ensuring the
internal market functions smoothly and that these systems can benefit from the free movement of goods and services. The rules must be clear and strong in protecting
fundamental rights, encourage innovative solutions, and foster a European ecosystem of public and private entities creating
AI systems that align with EU values, thereby maximizing the potential of digital transformation across all EU regions.
the Treaties and, pursuant to Article 6 TEU, the
Charter. As a prerequisite, AI should be a human-centric technology. It should serve as a tool for people, with the
ultimate aim of increasing human well-being.
(7)
In order to ensure a consistent and high level of protection of public interests as regards health, safety and
fundamental rights, common rules for high-risk AI systems should be established. Those rules should be consistent
with the Charter, non-discriminatory and in line with the Union’s international trade commitments. They should
also take into account the European Declaration on Digital Rights and Principles for the Digital Decade and the
Ethics guidelines for trustworthy AI of the High-Level Expert Group on Artificial Intelligence (AI HLEG).
(8)
A Union legal framework laying down harmonised rules on AI is therefore needed to foster the development, use
and uptake of AI in the internal market that at the same time meets a high level of protection of public interests, such
as health and safety and the protection of fundamental rights, including democracy, the rule of law and
environmental protection as recognised and protected by Union law. To achieve that objective, rules regulating the
placing on the market, the putting into service and the use of certain AI systems should be laid down, thus ensuring
the smooth functioning of the internal market and allowing those systems to benefit from the principle of free
movement of goods and services. Those rules should be clear and robust in protecting fundamental rights,
supportive of new innovative solutions, enabling a European ecosystem of public and private actors creating AI
systems in line with Union values and unlocking the potential of the digital transformation across all regions of the
Union.
Show original text
The
regulation aims to protect
fundamental rights while encouraging innovative solutions. It seeks to create a European environment where both public and private organizations can develop
AI systems that align with European values. This will help unlock the benefits of digital transformation across all regions of the EU. The
regulation establishes rules and support measures, particularly for small and medium enterprises (
SMEs) and startups, to promote a human-centered approach to
AI. It also aims to position Europe as a global leader in developing secure, trustworthy, and ethical
AI, as emphasized by the European
Council, and ensures the protection of
ethical principles as requested by the
European Parliament. Additionally, consistent rules for the marketing, deployment, and use of
high-risk AI systems will be established in line with existing EU regulations.
clear and robust in protecting fundamental rights,
supportive of new innovative solutions, enabling a European ecosystem of public and private actors creating AI
systems in line with Union values and unlocking the potential of the digital transformation across all regions of the
Union. By laying down those rules as well as measures in support of innovation with a particular focus on small and
medium enterprises (SMEs), including startups, this Regulation supports the objective of promoting the European
human-centric approach to AI and being a global leader in the development of secure, trustworthy and ethical AI as
stated by the European Council (5), and it ensures the protection of ethical principles, as specifically requested by the
European Parliament (6).
EN
OJ L, 12.7.2024
2/144
ELI: http://data.europa.eu/eli/reg/2024/1689/oj
(5)
European Council, Special meeting of the European Council (1 and 2 October 2020) — Conclusions, EUCO 13/20, 2020, p. 6.
(6)
European Parliament resolution of 20 October 2020 with recommendations to the Commission on a framework of ethical aspects
of artificial intelligence, robotics and related technologies, 2020/2012(INL).
(9)
Harmonised rules applicable to the placing on the market, the putting into service and the use of high-risk AI
systems should be laid down consistently with Regulation (EC) No 765/2008 of the European Parliament and of the
Council (7), Decision No 768/2008/EC of the European Parliament and of the Council (8) and Regulation (EU)
2019/1020 of the European Parliament and of the Council (9) (New Legislative Framework).
Show original text
The harmonized rules in
Regulation (EU) 2019/1020, established by the
European Parliament and Council, apply to various sectors and complement existing EU laws on
data protection, consumer rights,
fundamental rights, employment, worker protection, and product safety. This means that all rights and remedies provided by these laws for consumers and others affected by
AI systems remain intact and fully applicable. Additionally, this
regulation does not change EU social policy or national labor laws regarding employment conditions,
health and safety, or employer-employee relationships. It also respects
fundamental rights recognized at both the national and EU levels, including the right to strike, negotiate, and enforce collective agreements according to national laws. Furthermore, it does not interfere with laws aimed at improving working conditions in platform work. The
regulation seeks to enhance the effectiveness of existing rights by setting specific requirements for
transparency,
technical documentation, and record-keeping for
AI systems.
(7), Decision No 768/2008/EC of the European Parliament and of the Council (8) and Regulation (EU)
2019/1020 of the European Parliament and of the Council (9) (New Legislative Framework). The harmonised rules
laid down in this Regulation should apply across sectors and, in line with the New Legislative Framework, should be
without prejudice to existing Union law, in particular on data protection, consumer protection, fundamental rights,
employment, and protection of workers, and product safety, to which this Regulation is complementary. As
a consequence, all rights and remedies provided for by such Union law to consumers, and other persons on whom
AI systems may have a negative impact, including as regards the compensation of possible damages pursuant to
Council Directive 85/374/EEC (10) remain unaffected and fully applicable. Furthermore, in the context of
employment and protection of workers, this Regulation should therefore not affect Union law on social policy and
national labour law, in compliance with Union law, concerning employment and working conditions, including
health and safety at work and the relationship between employers and workers. This Regulation should also not
affect the exercise of fundamental rights as recognised in the Member States and at Union level, including the right or
freedom to strike or to take other action covered by the specific industrial relations systems in Member States as well
as the right to negotiate, to conclude and enforce collective agreements or to take collective action in accordance
with national law. This Regulation should not affect the provisions aiming to improve working conditions in
platform work laid down in a Directive of the European Parliament and of the Council on improving working
conditions in platform work. Moreover, this Regulation aims to strengthen the effectiveness of such existing rights
and remedies by establishing specific requirements and obligations, including in respect of the transparency,
technical documentation and record-keeping of AI systems.
Show original text
on improving working
conditions in platform work. Moreover, this Regulation aims to strengthen the effectiveness of such existing rights
and remedies by establishing specific requirements and obligations, including in respect of the transparency,
technical documentation and record-keeping of AI systems. Furthermore, the obligations placed on various
operators involved in the AI value chain under this Regulation should apply without prejudice to national law, in
compliance with Union law, having the effect of limiting the use of certain AI systems where such law falls outside
the scope of this Regulation or pursues legitimate public interest objectives other than those pursued by this
Regulation. For example, national labour law and law on the protection of minors, namely persons below the age of
18, taking into account the UNCRC General Comment No 25 (2021) on children’s rights in relation to the digital
environment, insofar as they are not specific to AI systems and pursue other legitimate public interest objectives,
should not be affected by this Regulation.
(10)
The fundamental right to the protection of personal data is safeguarded in particular by Regulations (EU)
2016/679 (11) and (EU) 2018/1725 (12) of the European Parliament and of the Council and Directive (EU) 2016/680
of the European Parliament and of the Council (13). Directive 2002/58/EC of the European Parliament and of the
Council (14) additionally protects private life and the confidentiality of communications, including by way of
providing conditions for any storing of personal and non-personal data in, and access from, terminal equipment.
Those Union legal acts provide the basis for sustainable and responsible data processing, including where data sets
include a mix of personal and non-personal data.
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This
regulation covers the storage and access of both personal and non-
personal data on devices. It establishes guidelines for responsible
data processing, even when
data sets contain a mix of both types of
data. The
regulation does not change existing EU laws on
personal data processing or the roles of independent supervisory authorities that ensure compliance with these laws. It also does not alter the responsibilities of
AI system providers and
users regarding
personal data protection under EU or national laws when they design, develop, or use
AI systems that process
personal data. Additionally, individuals whose
data is being processed continue to have all their rights protected.
for any storing of personal and non-personal data in, and access from, terminal equipment.
Those Union legal acts provide the basis for sustainable and responsible data processing, including where data sets
include a mix of personal and non-personal data. This Regulation does not seek to affect the application of existing
Union law governing the processing of personal data, including the tasks and powers of the independent supervisory
authorities competent to monitor compliance with those instruments. It also does not affect the obligations of
providers and deployers of AI systems in their role as data controllers or processors stemming from Union or
national law on the protection of personal data in so far as the design, the development or the use of AI systems
involves the processing of personal data. It is also appropriate to clarify that data subjects continue to enjoy all the
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(7)
Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for
accreditation and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).
(8)
Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the
marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
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On July 9, 2008, a
regulation was established to create a common framework for marketing products, replacing
Council Decision 93/465/EEC (Official Journal L 218, August 13, 2008, page 82). On June 20, 2019,
Regulation (EU) 2019/1020 was enacted by the
European Parliament and Council to enhance market surveillance and ensure product compliance, amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (Official Journal L 169, June 25, 2019, page 1). Additionally,
Council Directive 85/374/EEC, adopted on July 25, 1985, aimed to harmonize laws across
Member States regarding liability for defective products (Official Journal L 210, August 7, 1985, page 29). The General
Data Protection
Regulation (
Regulation (EU) 2016/679), which protects individuals'
personal data and allows for its free movement, was passed on April 27, 2016, replacing Directive 95/46/EC (Official Journal L 119, May 4, 2016, page 1). Lastly,
Regulation (EU) 2018/1725, adopted on October 23, 2018, focuses on the protection of
personal data processed by EU institutions and repeals
Regulation (EC) No 45/2001 and
Decision No 1247/2002/EC (Official Journal L 295, November 21, 2018, page 39).
of 9 July 2008 on a common framework for the
marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
(9)
Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance
of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019,
p. 1).
(10)
Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the
Member States concerning liability for defective products (OJ L 210, 7.8.1985, p. 29).
(11)
Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons
with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General
Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).
(12)
Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural
persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free
movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
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movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
(13)
Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with
regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or
prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing
Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, p. 89).
(14)
Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data
and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ
L 201, 31.7.2002, p. 37).
rights and guarantees awarded to them by such Union law, including the rights related to solely automated individual
decision-making, including profiling. Harmonised rules for the placing on the market, the putting into service and
the use of AI systems established under this Regulation should facilitate the effective implementation and enable the
exercise of the data subjects’ rights and other remedies guaranteed under Union law on the protection of personal
data and of other fundamental rights.
(11)
This Regulation should be without prejudice to the provisions regarding the liability of providers of intermediary
services as set out in Regulation (EU) 2022/2065 of the European Parliament and of the Council (15).
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This
Regulation does not affect the rules about the responsibility of intermediary service
providers as stated in
Regulation (EU) 2022/2065 by the
European Parliament and Council. The term '
AI system' in this
Regulation needs a clear definition that aligns with international organizations working on
AI. This will help ensure legal clarity, promote global agreement, and allow for quick adaptation to new technology. The definition should highlight the unique features of
AI systems that set them apart from simpler software and should not include systems that only follow rules set by humans to perform tasks automatically. A key feature of
AI systems is their ability to infer, which means they can generate outputs like predictions, recommendations, or decisions that can affect both physical and digital environments.
AI systems can create models or algorithms from
data inputs. Techniques that enable this inference include machine learning, which learns from
data to meet specific goals, and logic-based methods that use encoded knowledge to solve tasks. The ability to infer goes beyond basic
data processing, allowing for learning, reasoning, and modeling. The term 'machine-based' indicates that
AI systems operate on machines. The mention of explicit or implicit objectives means that
AI systems can work towards clearly defined goals or more vague, underlying goals, which may differ from their intended purpose in a given situation.
other fundamental rights.
(11)
This Regulation should be without prejudice to the provisions regarding the liability of providers of intermediary
services as set out in Regulation (EU) 2022/2065 of the European Parliament and of the Council (15).
(12)
The notion of ‘AI system’ in this Regulation should be clearly defined and should be closely aligned with the work of
international organisations working on AI to ensure legal certainty, facilitate international convergence and wide
acceptance, while providing the flexibility to accommodate the rapid technological developments in this field.
Moreover, the definition should be based on key characteristics of AI systems that distinguish it from simpler
traditional software systems or programming approaches and should not cover systems that are based on the rules
defined solely by natural persons to automatically execute operations. A key characteristic of AI systems is their
capability to infer. This capability to infer refers to the process of obtaining the outputs, such as predictions, content,
recommendations, or decisions, which can influence physical and virtual environments, and to a capability of AI
systems to derive models or algorithms, or both, from inputs or data. The techniques that enable inference while
building an AI system include machine learning approaches that learn from data how to achieve certain objectives,
and logic- and knowledge-based approaches that infer from encoded knowledge or symbolic representation of the
task to be solved. The capacity of an AI system to infer transcends basic data processing by enabling learning,
reasoning or modelling. The term ‘machine-based’ refers to the fact that AI systems run on machines. The reference
to explicit or implicit objectives underscores that AI systems can operate according to explicit defined objectives or
to implicit objectives. The objectives of the AI system may be different from the intended purpose of the AI system
in a specific context.
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AI systems can operate based on clear (explicit) goals or implied (implicit) goals. Sometimes, the goals of an
AI system may differ from its intended use in a specific situation. In this
regulation, 'environments' refer to the contexts where
AI systems function, while 'outputs' are the results produced by these systems, such as predictions, content, recommendations, or decisions.
AI systems can work with different levels of independence from human control and can adapt and learn after being deployed. They can be used on their own or as part of a product, whether they are built into the product (embedded) or function separately (non-embedded). The term '
deployer' in this
regulation refers to any individual or organization, including
public authorities, that uses an
AI system under their control, except when the system is used for personal, non-professional purposes. Depending on the type of
AI system, its use may impact people other than the
deployer. The term '
biometric data' in this
regulation is defined according to specific articles in EU regulations concerning
data protection.
machines. The reference
to explicit or implicit objectives underscores that AI systems can operate according to explicit defined objectives or
to implicit objectives. The objectives of the AI system may be different from the intended purpose of the AI system
in a specific context. For the purposes of this Regulation, environments should be understood to be the contexts in
which the AI systems operate, whereas outputs generated by the AI system reflect different functions performed by
AI systems and include predictions, content, recommendations or decisions. AI systems are designed to operate with
varying levels of autonomy, meaning that they have some degree of independence of actions from human
involvement and of capabilities to operate without human intervention. The adaptiveness that an AI system could
exhibit after deployment, refers to self-learning capabilities, allowing the system to change while in use. AI systems
can be used on a stand-alone basis or as a component of a product, irrespective of whether the system is physically
integrated into the product (embedded) or serves the functionality of the product without being integrated therein
(non-embedded).
(13)
The notion of ‘deployer’ referred to in this Regulation should be interpreted as any natural or legal person, including
a public authority, agency or other body, using an AI system under its authority, except where the AI system is used
in the course of a personal non-professional activity. Depending on the type of AI system, the use of the system may
affect persons other than the deployer.
(14)
The notion of ‘biometric data’ used in this Regulation should be interpreted in light of the notion of biometric data
as defined in Article 4, point (14) of Regulation (EU) 2016/679, Article 3, point (18) of Regulation (EU) 2018/1725
and Article 3, point (13) of Directive (EU) 2016/680.
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Regulation (EU) 2016/679,
Article 3, point (18) of
Regulation (EU) 2018/1725, and
Article 3, point (13) of
Directive (EU) 2016/680 define
biometric data as information that can be used to identify, authenticate, or categorize individuals, as well as recognize their emotions. 'Biometric identification' is described as the automated process of recognizing human physical, physiological, and behavioral traits, such as facial features, eye movement, body shape, voice, walking style, posture, heart rate, blood pressure, scent, and typing patterns. This process is used to establish a person's identity by comparing their
biometric data to
data stored in a reference database, regardless of whether the person has given consent. However, this does not include
AI systems used solely for biometric verification, which is meant to confirm that a person is who they claim to be for accessing services, unlocking devices, or gaining security access to locations. Additionally,
Regulation (EU) 2022/2065, passed on October 19, 2022, addresses the Single Market for Digital Services and amends
Directive 2000/31/EC (
Digital Services Act).
Regulation (EU) 2016/679, Article 3, point (18) of Regulation (EU) 2018/1725
and Article 3, point (13) of Directive (EU) 2016/680. Biometric data can allow for the authentication, identification
or categorisation of natural persons and for the recognition of emotions of natural persons.
(15)
The notion of ‘biometric identification’ referred to in this Regulation should be defined as the automated recognition
of physical, physiological and behavioural human features such as the face, eye movement, body shape, voice,
prosody, gait, posture, heart rate, blood pressure, odour, keystrokes characteristics, for the purpose of establishing an
individual’s identity by comparing biometric data of that individual to stored biometric data of individuals in
a reference database, irrespective of whether the individual has given its consent or not. This excludes AI systems
intended to be used for biometric verification, which includes authentication, whose sole purpose is to confirm that
a specific natural person is the person he or she claims to be and to confirm the identity of a natural person for the
sole purpose of having access to a service, unlocking a device or having security access to premises.
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(15)
Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market For Digital
Services and amending Directive 2000/31/EC (Digital Services Act) (OJ L 277, 27.10.2022, p. 1).
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On October 19, 2022, the
Digital Services Act was established, amending
Directive 2000/31/EC (published in
OJ L 277 on October 27, 2022, page 1).
The term '
biometric categorisation' in this
regulation refers to the process of classifying individuals based on their
biometric data. This classification can include factors like sex, age, hair color, eye color, tattoos, behavioral traits, personality traits, language, religion, membership in a national minority, and sexual or political orientation.
However, this does not apply to
biometric categorisation systems that are merely additional features tied to another main service. These features cannot be used independently for technical reasons, and their inclusion should not be a way to avoid the rules of this
regulation.
For instance, filters that categorize facial or body features on
online marketplaces are considered ancillary features because they can only be used in connection with the main service of selling products, helping consumers preview items on themselves to aid in their purchasing decisions. Similarly, filters on social networking sites that categorize facial or body features for modifying pictures or videos are also ancillary, as they cannot function without the primary service of sharing content online.
19 October 2022 on a Single Market For Digital
Services and amending Directive 2000/31/EC (Digital Services Act) (OJ L 277, 27.10.2022, p. 1).
(16)
The notion of ‘biometric categorisation’ referred to in this Regulation should be defined as assigning natural persons
to specific categories on the basis of their biometric data. Such specific categories can relate to aspects such as sex,
age, hair colour, eye colour, tattoos, behavioural or personality traits, language, religion, membership of a national
minority, sexual or political orientation. This does not include biometric categorisation systems that are a purely
ancillary feature intrinsically linked to another commercial service, meaning that the feature cannot, for objective
technical reasons, be used without the principal service, and the integration of that feature or functionality is not
a means to circumvent the applicability of the rules of this Regulation. For example, filters categorising facial or body
features used on online marketplaces could constitute such an ancillary feature as they can be used only in relation to
the principal service which consists in selling a product by allowing the consumer to preview the display of the
product on him or herself and help the consumer to make a purchase decision. Filters used on online social network
services which categorise facial or body features to allow users to add or modify pictures or videos could also be
considered to be ancillary feature as such filter cannot be used without the principal service of the social network
services consisting in the sharing of content online.
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Features that use facial or body characteristics to let
users edit pictures or videos are considered secondary because they rely on the main function of social networks, which is sharing content online.
The term '
remote biometric identification system' in this
Regulation refers to an
AI system designed to identify people without their active participation, usually from a distance. This is done by comparing a person's
biometric data, like
fingerprints or facial recognition, with
data stored in a reference database, regardless of the technology or type of
biometric data used. These systems can observe multiple people or their behaviors at once, making it easier to identify individuals without their involvement.
This definition excludes
AI systems used for biometric verification, which only confirm a person's identity for access to services, unlocking devices, or security purposes. This exclusion is important because verification systems typically have a smaller impact on individuals' rights compared to remote identification systems that can process
data from many people without their consent.
In 'real-time' systems,
biometric data is captured, compared, and identified almost instantly, without significant delays. Therefore, the rules in this
Regulation regarding the real-time use of these
AI systems must be strictly followed, and there should be no loopholes that allow for minor delays.
ise facial or body features to allow users to add or modify pictures or videos could also be
considered to be ancillary feature as such filter cannot be used without the principal service of the social network
services consisting in the sharing of content online.
(17)
The notion of ‘remote biometric identification system’ referred to in this Regulation should be defined functionally,
as an AI system intended for the identification of natural persons without their active involvement, typically at
a distance, through the comparison of a person’s biometric data with the biometric data contained in a reference
database, irrespectively of the particular technology, processes or types of biometric data used. Such remote
biometric identification systems are typically used to perceive multiple persons or their behaviour simultaneously in
order to facilitate significantly the identification of natural persons without their active involvement. This excludes
AI systems intended to be used for biometric verification, which includes authentication, the sole purpose of which
is to confirm that a specific natural person is the person he or she claims to be and to confirm the identity of
a natural person for the sole purpose of having access to a service, unlocking a device or having security access to
premises. That exclusion is justified by the fact that such systems are likely to have a minor impact on fundamental
rights of natural persons compared to the remote biometric identification systems which may be used for the
processing of the biometric data of a large number of persons without their active involvement. In the case of
‘real-time’ systems, the capturing of the biometric data, the comparison and the identification occur all
instantaneously, near-instantaneously or in any event without a significant delay. In this regard, there should be no
scope for circumventing the rules of this Regulation on the ‘real-time’ use of the AI systems concerned by providing
for minor delays.
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AI systems must operate in real-time, meaning they should provide immediate results without significant delays. There should be no loopholes that allow for minor delays to bypass these rules.
Real-time systems use live or nearly live
data, like video from cameras. In contrast, post systems analyze
biometric data that has already been collected, with identification happening only after a considerable delay. This includes footage from CCTV or other devices that was recorded before the system is used on individuals.
The term '
emotion recognition system' in this
regulation refers to
AI systems that identify or infer the emotions or intentions of individuals based on their
biometric data. This includes emotions like happiness, sadness, anger, surprise, disgust, embarrassment, excitement, shame, contempt, satisfaction, and amusement. It does not cover physical states like pain or fatigue, such as systems that detect fatigue in pilots or
drivers to prevent accidents. Additionally, it does not include simply recognizing obvious expressions, gestures, or movements unless they are specifically used to identify or infer emotions. Examples of these expressions include basic facial expressions like frowning or smiling, hand or arm movements, and vocal characteristics like a raised voice or whispering.
near-instantaneously or in any event without a significant delay. In this regard, there should be no
scope for circumventing the rules of this Regulation on the ‘real-time’ use of the AI systems concerned by providing
for minor delays. ‘Real-time’ systems involve the use of ‘live’ or ‘near-live’ material, such as video footage, generated
by a camera or other device with similar functionality. In the case of ‘post’ systems, in contrast, the biometric data
has already been captured and the comparison and identification occur only after a significant delay. This involves
material, such as pictures or video footage generated by closed circuit television cameras or private devices, which
has been generated before the use of the system in respect of the natural persons concerned.
(18)
The notion of ‘emotion recognition system’ referred to in this Regulation should be defined as an AI system for the
purpose of identifying or inferring emotions or intentions of natural persons on the basis of their biometric data.
The notion refers to emotions or intentions such as happiness, sadness, anger, surprise, disgust, embarrassment,
excitement, shame, contempt, satisfaction and amusement. It does not include physical states, such as pain or
fatigue, including, for example, systems used in detecting the state of fatigue of professional pilots or drivers for the
purpose of preventing accidents. This does also not include the mere detection of readily apparent expressions,
gestures or movements, unless they are used for identifying or inferring emotions. Those expressions can be basic
facial expressions, such as a frown or a smile, or gestures such as the movement of hands, arms or head, or
characteristics of a person’s voice, such as a raised voice or whispering.
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Expressions can include basic facial expressions like frowning or smiling, gestures such as moving hands, arms, or head, and vocal characteristics like speaking loudly or whispering.
In this
regulation, '
publicly accessible space' means any physical area that anyone can enter, regardless of whether it is privately or publicly owned. This includes places used for various activities, such as:
- Commerce: shops, restaurants, cafés
- Services: banks, professional offices, hospitality
- Sports: swimming pools, gyms, stadiums
- Transport: bus, metro, and railway stations, airports
- Entertainment: cinemas, theatres, museums, concert halls, conference halls
- Leisure: public roads, squares, parks, forests, playgrounds.
A space is also considered publicly accessible if it has certain conditions for entry that can be met by many people, such as buying a ticket, registering in advance, or meeting an age requirement. However, a space is not publicly accessible if entry is restricted to specific individuals due to laws related to public safety or security, or if the owner clearly indicates that access is limited.
expressions can be basic
facial expressions, such as a frown or a smile, or gestures such as the movement of hands, arms or head, or
characteristics of a person’s voice, such as a raised voice or whispering.
(19)
For the purposes of this Regulation the notion of ‘publicly accessible space’ should be understood as referring to any
physical space that is accessible to an undetermined number of natural persons, and irrespective of whether the
space in question is privately or publicly owned, irrespective of the activity for which the space may be used, such as
for commerce, for example, shops, restaurants, cafés; for services, for example, banks, professional activities,
hospitality; for sport, for example, swimming pools, gyms, stadiums; for transport, for example, bus, metro and
railway stations, airports, means of transport; for entertainment, for example, cinemas, theatres, museums, concert
and conference halls; or for leisure or otherwise, for example, public roads and squares, parks, forests, playgrounds.
A space should also be classified as being publicly accessible if, regardless of potential capacity or security
restrictions, access is subject to certain predetermined conditions which can be fulfilled by an undetermined number
of persons, such as the purchase of a ticket or title of transport, prior registration or having a certain age. In contrast,
a space should not be considered to be publicly accessible if access is limited to specific and defined natural persons
through either Union or national law directly related to public safety or security or through the clear manifestation
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of will by the person having the relevant authority over the space.
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On July 12, 2024, the
European Union published regulations regarding public accessibility of spaces. Access to a space is determined by the authority in charge. Just because a door is unlocked or a gate is open does not mean the space is publicly accessible, especially if there are signs indicating restrictions. Areas like company premises, factories, and offices meant only for employees and service
providers are not considered publicly accessible. Additionally, prisons and border control areas are excluded from public access. Some locations, like hallways in private buildings that lead to offices or airports, may have both public and restricted areas. Online spaces are not included in this definition, as they are not physical locations. Each space's accessibility should be evaluated individually based on its specific circumstances. To maximize the benefits of
AI systems while safeguarding
fundamental rights and ensuring democratic oversight, it is essential for
providers,
users, and those affected to have a good understanding of
AI. This includes knowledge about the development and application of
AI technology, how to interpret its results, and how
AI-driven decisions may affect individuals.
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of will by the person having the relevant authority over the space. The factual possibility of access alone, such as an
unlocked door or an open gate in a fence, does not imply that the space is publicly accessible in the presence of
indications or circumstances suggesting the contrary, such as. signs prohibiting or restricting access. Company and
factory premises, as well as offices and workplaces that are intended to be accessed only by relevant employees and
service providers, are spaces that are not publicly accessible. Publicly accessible spaces should not include prisons or
border control. Some other spaces may comprise both publicly accessible and non-publicly accessible spaces, such as
the hallway of a private residential building necessary to access a doctor’s office or an airport. Online spaces are not
covered, as they are not physical spaces. Whether a given space is accessible to the public should however be
determined on a case-by-case basis, having regard to the specificities of the individual situation at hand.
(20)
In order to obtain the greatest benefits from AI systems while protecting fundamental rights, health and safety and to
enable democratic control, AI literacy should equip providers, deployers and affected persons with the necessary
notions to make informed decisions regarding AI systems. Those notions may vary with regard to the relevant
context and can include understanding the correct application of technical elements during the AI system’s
development phase, the measures to be applied during its use, the suitable ways in which to interpret the AI system’s
output, and, in the case of affected persons, the knowledge necessary to understand how decisions taken with the
assistance of AI will have an impact on them.
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The
AI system's output must be interpreted correctly, and affected individuals need to understand how
AI-assisted decisions will impact them. This
Regulation aims to ensure that everyone involved in the
AI value chain has the knowledge necessary for compliance and enforcement. Promoting
AI literacy can improve working conditions and support the development of trustworthy
AI in the
European Union. The
European Artificial Intelligence Board will assist the
Commission in promoting
AI literacy tools and raising public awareness about the benefits, risks, and rights related to
AI systems. The
Commission and
Member States will work with
stakeholders to create voluntary
codes of conduct to enhance
AI literacy for those involved in developing, operating, and using
AI. To protect individual rights across the
Union, the rules in this
Regulation will apply equally to
AI system providers, regardless of whether they are based in the
Union or abroad, as well as to
users of
AI systems within the
Union. Additionally, some
AI systems will be covered by this
Regulation even if they are not marketed or used in the
Union, especially when a
Union-based
operator contracts services from a third-country
operator for high-risk
AI activities.
applied during its use, the suitable ways in which to interpret the AI system’s
output, and, in the case of affected persons, the knowledge necessary to understand how decisions taken with the
assistance of AI will have an impact on them. In the context of the application this Regulation, AI literacy should
provide all relevant actors in the AI value chain with the insights required to ensure the appropriate compliance and
its correct enforcement. Furthermore, the wide implementation of AI literacy measures and the introduction of
appropriate follow-up actions could contribute to improving working conditions and ultimately sustain the
consolidation, and innovation path of trustworthy AI in the Union. The European Artificial Intelligence Board (the
‘Board’) should support the Commission, to promote AI literacy tools, public awareness and understanding of the
benefits, risks, safeguards, rights and obligations in relation to the use of AI systems. In cooperation with the relevant
stakeholders, the Commission and the Member States should facilitate the drawing up of voluntary codes of conduct
to advance AI literacy among persons dealing with the development, operation and use of AI.
(21)
In order to ensure a level playing field and an effective protection of rights and freedoms of individuals across the
Union, the rules established by this Regulation should apply to providers of AI systems in a non-discriminatory
manner, irrespective of whether they are established within the Union or in a third country, and to deployers of AI
systems established within the Union.
(22)
In light of their digital nature, certain AI systems should fall within the scope of this Regulation even when they are
not placed on the market, put into service, or used in the Union. This is the case, for example, where an operator
established in the Union contracts certain services to an operator established in a third country in relation to an
activity to be performed by an AI system that would qualify as high-risk.
Show original text
This
regulation applies when a company in the
European Union hires a company in a non-EU country to provide services related to a
high-risk AI system. In this case, the
AI system in the non-EU country can legally process
data collected from the EU and send the results back to the EU company without being sold or used in the EU. To prevent bypassing this
regulation and to protect individuals in the EU, the
regulation also applies to
AI system providers and
users in non-EU countries if their outputs are meant for use in the EU. However, this
regulation does not apply to
public authorities or international organizations from non-EU countries when they are cooperating under international agreements for
law enforcement and judicial matters with the EU or its
member states, as long as they ensure adequate protection of individual rights. This includes activities by entities designated by non-EU countries to assist in such cooperation. These cooperation frameworks or agreements can be established between EU
member states and non-EU countries or between the EU,
Europol, and other EU agencies and non-EU countries and organizations.
Union. This is the case, for example, where an operator
established in the Union contracts certain services to an operator established in a third country in relation to an
activity to be performed by an AI system that would qualify as high-risk. In those circumstances, the AI system used
in a third country by the operator could process data lawfully collected in and transferred from the Union, and
provide to the contracting operator in the Union the output of that AI system resulting from that processing,
without that AI system being placed on the market, put into service or used in the Union. To prevent the
circumvention of this Regulation and to ensure an effective protection of natural persons located in the Union, this
Regulation should also apply to providers and deployers of AI systems that are established in a third country, to the
extent the output produced by those systems is intended to be used in the Union. Nonetheless, to take into account
existing arrangements and special needs for future cooperation with foreign partners with whom information and
evidence is exchanged, this Regulation should not apply to public authorities of a third country and international
organisations when acting in the framework of cooperation or international agreements concluded at Union or
national level for law enforcement and judicial cooperation with the Union or the Member States, provided that the
relevant third country or international organisation provides adequate safeguards with respect to the protection of
fundamental rights and freedoms of individuals. Where relevant, this may cover activities of entities entrusted by the
third countries to carry out specific tasks in support of such law enforcement and judicial cooperation. Such
framework for cooperation or agreements have been established bilaterally between Member States and third
countries or between the European Union, Europol and other Union agencies and third countries and international
organisations.
Show original text
This
regulation supports cooperation between
law enforcement and judicial authorities. Agreements for this cooperation have been made between EU
Member States, third countries,
Europol, and other EU agencies. The authorities responsible for overseeing
law enforcement and judicial bodies must check that these cooperation frameworks and international agreements protect individuals'
fundamental rights and freedoms.
National authorities and EU institutions using these agreements must ensure their actions comply with EU law. When revising or creating new international agreements, parties should strive to align them with this
regulation's requirements. Additionally, this
regulation applies to EU institutions, bodies, offices, and agencies when they provide or deploy
AI systems. However,
AI systems used for military, defense, or national security purposes are excluded from this
regulation, regardless of whether they are operated by public or private entities.
support of such law enforcement and judicial cooperation. Such
framework for cooperation or agreements have been established bilaterally between Member States and third
countries or between the European Union, Europol and other Union agencies and third countries and international
organisations. The authorities competent for supervision of the law enforcement and judicial authorities under this
Regulation should assess whether those frameworks for cooperation or international agreements include adequate
safeguards with respect to the protection of fundamental rights and freedoms of individuals. Recipient national
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authorities and Union institutions, bodies, offices and agencies making use of such outputs in the Union remain
accountable to ensure their use complies with Union law. When those international agreements are revised or new
ones are concluded in the future, the contracting parties should make utmost efforts to align those agreements with
the requirements of this Regulation.
(23)
This Regulation should also apply to Union institutions, bodies, offices and agencies when acting as a provider or
deployer of an AI system.
(24)
If, and insofar as, AI systems are placed on the market, put into service, or used with or without modification of such
systems for military, defence or national security purposes, those should be excluded from the scope of this
Regulation regardless of which type of entity is carrying out those activities, such as whether it is a public or private
entity.
Show original text
AI systems designed for military, defense, or national security purposes are not covered by this
Regulation, regardless of whether they are operated by public or private entities. This exclusion is supported by
Article 4(2) of the Treaty on
European Union (
TEU) and the specific needs of
Member States' defense policies, which are governed by international law. For national security, the exclusion is justified because it is the sole responsibility of
Member States, as stated in
Article 4(2) TEU, and due to the unique requirements of national security operations. However, if an
AI system originally developed for military, defense, or national security purposes is later used for civilian, humanitarian,
law enforcement, or
public security purposes, it will then fall under this
Regulation. In such cases, the entity using the
AI system for these other purposes must ensure that it complies with the
Regulation, unless it already meets the requirements. Additionally,
AI systems that are marketed or used for both excluded (military, defense, national security) and non-excluded (civilian,
law enforcement) purposes must comply with this
Regulation, and the
providers of these systems are responsible for ensuring compliance.
modification of such
systems for military, defence or national security purposes, those should be excluded from the scope of this
Regulation regardless of which type of entity is carrying out those activities, such as whether it is a public or private
entity. As regards military and defence purposes, such exclusion is justified both by Article 4(2) TEU and by the
specificities of the Member States’ and the common Union defence policy covered by Chapter 2 of Title V TEU that
are subject to public international law, which is therefore the more appropriate legal framework for the regulation of
AI systems in the context of the use of lethal force and other AI systems in the context of military and defence
activities. As regards national security purposes, the exclusion is justified both by the fact that national security
remains the sole responsibility of Member States in accordance with Article 4(2) TEU and by the specific nature and
operational needs of national security activities and specific national rules applicable to those activities. Nonetheless,
if an AI system developed, placed on the market, put into service or used for military, defence or national security
purposes is used outside those temporarily or permanently for other purposes, for example, civilian or humanitarian
purposes, law enforcement or public security purposes, such a system would fall within the scope of this Regulation.
In that case, the entity using the AI system for other than military, defence or national security purposes should
ensure the compliance of the AI system with this Regulation, unless the system is already compliant with this
Regulation. AI systems placed on the market or put into service for an excluded purpose, namely military, defence or
national security, and one or more non-excluded purposes, such as civilian purposes or law enforcement, fall within
the scope of this Regulation and providers of those systems should ensure compliance with this Regulation.
Show original text
This
Regulation applies to
AI systems that serve both military, defense, or national security purposes (which are excluded) and civilian or
law enforcement purposes (which are included).
Providers of these systems must comply with the
Regulation. However, the
Regulation does not restrict entities from using
AI systems for national security, military, or defense activities, even if those systems are also used for
civilian purposes. If an
AI system is designed for civilian or
law enforcement use but is later used for military or national security purposes, it is not
subject to this
Regulation, regardless of who is using it.
Additionally, this
Regulation aims to promote innovation and protect scientific freedom, so
AI systems created solely for
scientific research and development are excluded from its scope. It is important that this
Regulation does not interfere with research and development activities related to
AI systems before they are marketed or put into use. For product-oriented research, testing, and development of
AI systems, the
Regulation does not apply until those systems are officially launched. However, once an
AI system developed through research is marketed or used, it must comply with the
Regulation, including any relevant provisions for
AI regulatory sandboxes and real-world testing.
an excluded purpose, namely military, defence or
national security, and one or more non-excluded purposes, such as civilian purposes or law enforcement, fall within
the scope of this Regulation and providers of those systems should ensure compliance with this Regulation. In those
cases, the fact that an AI system may fall within the scope of this Regulation should not affect the possibility of
entities carrying out national security, defence and military activities, regardless of the type of entity carrying out
those activities, to use AI systems for national security, military and defence purposes, the use of which is excluded
from the scope of this Regulation. An AI system placed on the market for civilian or law enforcement purposes
which is used with or without modification for military, defence or national security purposes should not fall within
the scope of this Regulation, regardless of the type of entity carrying out those activities.
(25)
This Regulation should support innovation, should respect freedom of science, and should not undermine research
and development activity. It is therefore necessary to exclude from its scope AI systems and models specifically
developed and put into service for the sole purpose of scientific research and development. Moreover, it is necessary
to ensure that this Regulation does not otherwise affect scientific research and development activity on AI systems or
models prior to being placed on the market or put into service. As regards product-oriented research, testing and
development activity regarding AI systems or models, the provisions of this Regulation should also not apply prior
to those systems and models being put into service or placed on the market. That exclusion is without prejudice to
the obligation to comply with this Regulation where an AI system falling into the scope of this Regulation is placed
on the market or put into service as a result of such research and development activity and to the application of
provisions on AI regulatory sandboxes and testing in real world conditions.
Show original text
This
regulation applies to
AI systems that are marketed or used as a result of research and development activities, including those tested in real-world conditions.
AI systems specifically created for scientific research are excluded from this
regulation, but other
AI systems used in research must still comply with its provisions. All research and development must adhere to recognized ethical and professional standards and applicable EU laws.
To create effective rules for
AI systems, a risk-based approach will be used. This means that the rules will be tailored based on the level of risk posed by different
AI systems. Certain harmful
AI practices will be banned,
high-risk AI systems will have specific requirements, and
transparency obligations will be established for some
AI systems.
Additionally, while this risk-based approach is essential, it is important to remember the
2019 Ethics Guidelines for Trustworthy AI created by the independent
AI High-Level Expert Group (HLEG) appointed by the
Commission. These guidelines outline seven non-binding
ethical principles to ensure that
AI is trustworthy and ethically responsible.
where an AI system falling into the scope of this Regulation is placed
on the market or put into service as a result of such research and development activity and to the application of
provisions on AI regulatory sandboxes and testing in real world conditions. Furthermore, without prejudice to the
exclusion of AI systems specifically developed and put into service for the sole purpose of scientific research and
development, any other AI system that may be used for the conduct of any research and development activity should
remain subject to the provisions of this Regulation. In any event, any research and development activity should be
carried out in accordance with recognised ethical and professional standards for scientific research and should be
conducted in accordance with applicable Union law.
(26)
In order to introduce a proportionate and effective set of binding rules for AI systems, a clearly defined risk-based
approach should be followed. That approach should tailor the type and content of such rules to the intensity and
scope of the risks that AI systems can generate. It is therefore necessary to prohibit certain unacceptable AI practices,
to lay down requirements for high-risk AI systems and obligations for the relevant operators, and to lay down
transparency obligations for certain AI systems.
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(27)
While the risk-based approach is the basis for a proportionate and effective set of binding rules, it is important to
recall the 2019 Ethics guidelines for trustworthy AI developed by the independent AI HLEG appointed by the
Commission. In those guidelines, the AI HLEG developed seven non-binding ethical principles for AI which are
intended to help ensure that AI is trustworthy and ethically sound.
Show original text
The independent
AI High-Level Expert Group (
AI HLEG), appointed by the
Commission, has created guidelines for trustworthy
AI. These guidelines outline seven
ethical principles that are not legally binding but aim to ensure
AI is reliable and ethical. The seven principles are: 1) Human agency and oversight, which means
AI should serve people, respect human dignity, and be controllable by humans; 2) Technical
robustness and safety, ensuring
AI systems are reliable and resistant to misuse; 3) Privacy and
data governance, which requires adherence to
data protection laws and high standards for
data quality; 4)
Transparency, allowing
users to understand and trace
AI decisions, and informing them when they interact with
AI; 5) Diversity, non-
discrimination, and fairness; 6) Societal and environmental well-being; and 7) Accountability. These guidelines support the creation of
AI that is coherent, trustworthy, and centered on human values, in line with the
Charter and the principles of the
Union.
guidelines for trustworthy AI developed by the independent AI HLEG appointed by the
Commission. In those guidelines, the AI HLEG developed seven non-binding ethical principles for AI which are
intended to help ensure that AI is trustworthy and ethically sound. The seven principles include human agency and
oversight; technical robustness and safety; privacy and data governance; transparency; diversity, non-discrimination
and fairness; societal and environmental well-being and accountability. Without prejudice to the legally binding
requirements of this Regulation and any other applicable Union law, those guidelines contribute to the design of
coherent, trustworthy and human-centric AI, in line with the Charter and with the values on which the Union is
founded. According to the guidelines of the AI HLEG, human agency and oversight means that AI systems are
developed and used as a tool that serves people, respects human dignity and personal autonomy, and that is
functioning in a way that can be appropriately controlled and overseen by humans. Technical robustness and safety
means that AI systems are developed and used in a way that allows robustness in the case of problems and resilience
against attempts to alter the use or performance of the AI system so as to allow unlawful use by third parties, and
minimise unintended harm. Privacy and data governance means that AI systems are developed and used in
accordance with privacy and data protection rules, while processing data that meets high standards in terms of
quality and integrity. Transparency means that AI systems are developed and used in a way that allows appropriate
traceability and explainability, while making humans aware that they communicate or interact with an AI system, as
well as duly informing deployers of the capabilities and limitations of that AI system and affected persons about their
rights.
Show original text
AI systems should be designed to ensure traceability and explainability, making it clear to
users when they are interacting with
AI. Deployers must be informed about the
AI's capabilities and limitations, and individuals should be aware of their rights.
AI development must promote diversity, non-
discrimination, and fairness, ensuring equal access, gender equality, and cultural diversity while avoiding biases that violate laws. Additionally,
AI should be developed sustainably, benefiting society and the environment, with ongoing assessments of its long-term effects on individuals and democracy. These principles should guide the design and use of
AI models and inform
codes of conduct under this
Regulation. All
stakeholders, including industry, academia, civil society, and standardization organizations, are encouraged to adopt
ethical principles in creating best practices and standards. However,
AI can also be misused for manipulative and exploitative purposes, which contradicts
Union values like human dignity, freedom, equality, democracy, and
fundamental rights, including non-
discrimination,
data protection, privacy, and children's rights. Manipulative
AI techniques can lead individuals to make unwanted decisions, undermining their autonomy and free choice.
way that allows appropriate
traceability and explainability, while making humans aware that they communicate or interact with an AI system, as
well as duly informing deployers of the capabilities and limitations of that AI system and affected persons about their
rights. Diversity, non-discrimination and fairness means that AI systems are developed and used in a way that
includes diverse actors and promotes equal access, gender equality and cultural diversity, while avoiding
discriminatory impacts and unfair biases that are prohibited by Union or national law. Social and environmental
well-being means that AI systems are developed and used in a sustainable and environmentally friendly manner as
well as in a way to benefit all human beings, while monitoring and assessing the long-term impacts on the
individual, society and democracy. The application of those principles should be translated, when possible, in the
design and use of AI models. They should in any case serve as a basis for the drafting of codes of conduct under this
Regulation. All stakeholders, including industry, academia, civil society and standardisation organisations, are
encouraged to take into account, as appropriate, the ethical principles for the development of voluntary best
practices and standards.
(28)
Aside from the many beneficial uses of AI, it can also be misused and provide novel and powerful tools for
manipulative, exploitative and social control practices. Such practices are particularly harmful and abusive and
should be prohibited because they contradict Union values of respect for human dignity, freedom, equality,
democracy and the rule of law and fundamental rights enshrined in the Charter, including the right to
non-discrimination, to data protection and to privacy and the rights of the child.
(29)
AI-enabled manipulative techniques can be used to persuade persons to engage in unwanted behaviours, or to
deceive them by nudging them into decisions in a way that subverts and impairs their autonomy, decision-making
and free choices.
Show original text
AI can use manipulative techniques to persuade people to do things they don't want to do or to trick them into making decisions that undermine their freedom and ability to choose. Certain
AI systems that significantly distort human behavior and can cause serious harm—especially to physical or mental health or financial well-being—should be banned. These systems might use hidden audio, images, or videos that people can't consciously perceive, or other deceptive methods that affect their decision-making without their awareness. For example, technologies like
machine-brain interfaces or
virtual reality can control what people experience, potentially leading to harmful behavior changes. Additionally,
AI can take advantage of people's vulnerabilities, such as age, disabilities (as defined by EU Directive 2019/882), or specific social or economic situations, making them more susceptible to exploitation, like those living in
extreme poverty or belonging to
ethnic or religious minorities.
29)
AI-enabled manipulative techniques can be used to persuade persons to engage in unwanted behaviours, or to
deceive them by nudging them into decisions in a way that subverts and impairs their autonomy, decision-making
and free choices. The placing on the market, the putting into service or the use of certain AI systems with the
objective to or the effect of materially distorting human behaviour, whereby significant harms, in particular having
sufficiently important adverse impacts on physical, psychological health or financial interests are likely to occur, are
particularly dangerous and should therefore be prohibited. Such AI systems deploy subliminal components such as
audio, image, video stimuli that persons cannot perceive, as those stimuli are beyond human perception, or other
manipulative or deceptive techniques that subvert or impair person’s autonomy, decision-making or free choice in
ways that people are not consciously aware of those techniques or, where they are aware of them, can still be
deceived or are not able to control or resist them. This could be facilitated, for example, by machine-brain interfaces
or virtual reality as they allow for a higher degree of control of what stimuli are presented to persons, insofar as they
may materially distort their behaviour in a significantly harmful manner. In addition, AI systems may also otherwise
exploit the vulnerabilities of a person or a specific group of persons due to their age, disability within the meaning of
Directive (EU) 2019/882 of the European Parliament and of the Council (16), or a specific social or economic
situation that is likely to make those persons more vulnerable to exploitation such as persons living in extreme
poverty, ethnic or religious minorities.
Show original text
According to
Directive (EU) 2019/882 from the
European Parliament and Council, certain
AI systems can exploit vulnerable individuals, such as those living in
extreme poverty or belonging to
ethnic or religious minorities. These systems may be marketed or used in ways that significantly distort people's behavior, potentially causing harm to individuals or groups over time. Such practices should be banned. It's important to note that harm can occur even if the
AI provider or user did not intend to cause it, especially if the harm arises from unforeseen external factors beyond their control.
2019/882 of the European Parliament and of the Council (16), or a specific social or economic
situation that is likely to make those persons more vulnerable to exploitation such as persons living in extreme
poverty, ethnic or religious minorities. Such AI systems can be placed on the market, put into service or used with
the objective to or the effect of materially distorting the behaviour of a person and in a manner that causes or is
reasonably likely to cause significant harm to that or another person or groups of persons, including harms that may
be accumulated over time and should therefore be prohibited. It may not be possible to assume that there is an
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(16)
Directive (EU) 2019/882 of the European Parliament and of the Council of 17 April 2019 on the accessibility requirements for
products and services (OJ L 151, 7.6.2019, p. 70).
intention to distort behaviour where the distortion results from factors external to the AI system which are outside
the control of the provider or the deployer, namely factors that may not be reasonably foreseeable and therefore not
possible for the provider or the deployer of the AI system to mitigate. In any case, it is not necessary for the provider
or the deployer to have the intention to cause significant harm, provided that such harm results from the
manipulative or exploitative AI-enabled practices.
Show original text
AI systems must be designed to prevent harm. It doesn't matter if the
provider or user didn't intend to cause harm; if the
AI's manipulative or exploitative practices lead to
significant harm, it is still prohibited. These rules complement the
European Parliament's
Directive 2005/29/EC, which bans unfair commercial practices that harm consumers financially, regardless of whether they use
AI or not. However, lawful medical practices, like psychological treatment or physical rehabilitation, are not affected by these prohibitions as long as they follow legal and medical standards, such as obtaining explicit consent from patients or their legal representatives. Additionally, common advertising practices that comply with the law are not considered harmful manipulative
AI practices. Furthermore, using
biometric data, like facial recognition or
fingerprints, to infer someone's political beliefs,
union membership, religion, race, sexual orientation, or personal life is prohibited. This ban does not apply to lawful categorization of
biometric data, such as sorting images by hair or eye color for
law enforcement purposes. Lastly,
AI systems that score individuals socially, whether by public or private entities, can lead to
discrimination and the exclusion of certain groups.
of the AI system to mitigate. In any case, it is not necessary for the provider
or the deployer to have the intention to cause significant harm, provided that such harm results from the
manipulative or exploitative AI-enabled practices. The prohibitions for such AI practices are complementary to the
provisions contained in Directive 2005/29/EC of the European Parliament and of the Council (17), in particular unfair
commercial practices leading to economic or financial harms to consumers are prohibited under all circumstances,
irrespective of whether they are put in place through AI systems or otherwise. The prohibitions of manipulative and
exploitative practices in this Regulation should not affect lawful practices in the context of medical treatment such as
psychological treatment of a mental disease or physical rehabilitation, when those practices are carried out in
accordance with the applicable law and medical standards, for example explicit consent of the individuals or their
legal representatives. In addition, common and legitimate commercial practices, for example in the field of
advertising, that comply with the applicable law should not, in themselves, be regarded as constituting harmful
manipulative AI-enabled practices.
(30)
Biometric categorisation systems that are based on natural persons’ biometric data, such as an individual person’s
face or fingerprint, to deduce or infer an individuals’ political opinions, trade union membership, religious or
philosophical beliefs, race, sex life or sexual orientation should be prohibited. That prohibition should not cover the
lawful labelling, filtering or categorisation of biometric data sets acquired in line with Union or national law
according to biometric data, such as the sorting of images according to hair colour or eye colour, which can for
example be used in the area of law enforcement.
(31)
AI systems providing social scoring of natural persons by public or private actors may lead to discriminatory
outcomes and the exclusion of certain groups.
Show original text
AI systems that score individuals based on their social behavior or personal characteristics can lead to
discrimination and the exclusion of certain groups. This can violate people's rights to dignity, equality, and justice. These systems assess individuals using various
data points over time, which can result in unfair treatment in social situations unrelated to the original
data. Therefore, such scoring practices should be banned, although lawful evaluations for specific purposes under
Union and national law can continue.
Additionally, using
AI for real-time
remote biometric identification in public spaces for
law enforcement is highly intrusive. It can invade the privacy of many people, create a sense of constant surveillance, and discourage the exercise of
fundamental rights like freedom of assembly. Furthermore, inaccuracies in these
AI systems can lead to biased results, particularly affecting individuals based on age, ethnicity, race, sex, or disabilities.
hair colour or eye colour, which can for
example be used in the area of law enforcement.
(31)
AI systems providing social scoring of natural persons by public or private actors may lead to discriminatory
outcomes and the exclusion of certain groups. They may violate the right to dignity and non-discrimination and the
values of equality and justice. Such AI systems evaluate or classify natural persons or groups thereof on the basis of
multiple data points related to their social behaviour in multiple contexts or known, inferred or predicted personal
or personality characteristics over certain periods of time. The social score obtained from such AI systems may lead
to the detrimental or unfavourable treatment of natural persons or whole groups thereof in social contexts, which
are unrelated to the context in which the data was originally generated or collected or to a detrimental treatment that
is disproportionate or unjustified to the gravity of their social behaviour. AI systems entailing such unacceptable
scoring practices and leading to such detrimental or unfavourable outcomes should therefore be prohibited. That
prohibition should not affect lawful evaluation practices of natural persons that are carried out for a specific purpose
in accordance with Union and national law.
(32)
The use of AI systems for ‘real-time’ remote biometric identification of natural persons in publicly accessible spaces
for the purpose of law enforcement is particularly intrusive to the rights and freedoms of the concerned persons, to
the extent that it may affect the private life of a large part of the population, evoke a feeling of constant surveillance
and indirectly dissuade the exercise of the freedom of assembly and other fundamental rights. Technical inaccuracies
of AI systems intended for the remote biometric identification of natural persons can lead to biased results and entail
discriminatory effects. Such possible biased results and discriminatory effects are particularly relevant with regard to
age, ethnicity, race, sex or disabilities.
Show original text
AI systems used for identifying people remotely can produce biased results and lead to
discrimination, especially concerning age, ethnicity, race, sex, or disabilities. The immediate effects of these systems, along with limited chances for verification or correction during real-time use, pose significant risks to the rights and freedoms of individuals involved, particularly in
law enforcement contexts. Therefore, using these systems for
law enforcement should be banned, except in specific, narrowly defined situations where their use is essential for a significant
public interest that outweighs the risks. These situations include searching for certain crime victims, threats to life or safety, or identifying suspects of serious crimes listed in an annex to this
regulation, which are punishable by imprisonment in the relevant
Member State.
AI systems intended for the remote biometric identification of natural persons can lead to biased results and entail
discriminatory effects. Such possible biased results and discriminatory effects are particularly relevant with regard to
age, ethnicity, race, sex or disabilities. In addition, the immediacy of the impact and the limited opportunities for
further checks or corrections in relation to the use of such systems operating in real-time carry heightened risks for
the rights and freedoms of the persons concerned in the context of, or impacted by, law enforcement activities.
(33)
The use of those systems for the purpose of law enforcement should therefore be prohibited, except in exhaustively
listed and narrowly defined situations, where the use is strictly necessary to achieve a substantial public interest, the
importance of which outweighs the risks. Those situations involve the search for certain victims of crime including
missing persons; certain threats to the life or to the physical safety of natural persons or of a terrorist attack; and the
localisation or identification of perpetrators or suspects of the criminal offences listed in an annex to this Regulation,
where those criminal offences are punishable in the Member State concerned by a custodial sentence or a detention
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(17)
Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer
commercial practices in the internal market and amending Council Directive 84/450/EEC, Directives 97/7/EC, 98/27/EC and
2002/65/EC of the European Parliament and of the Council and Regulation (EC) No 2006/2004 of the European Parliament and of
the Council (‘Unfair Commercial Practices Directive’) (OJ L 149, 11
Show original text
/65/EC of the European Parliament and of the Council and Regulation (EC) No 2006/2004 of the European Parliament and of
the Council (‘Unfair Commercial Practices Directive’) (OJ L 149, 11.6.2005, p. 22).
order for a maximum period of at least four years and as they are defined in the law of that Member State. Such
a threshold for the custodial sentence or detention order in accordance with national law contributes to ensuring
that the offence should be serious enough to potentially justify the use of ‘real-time’ remote biometric identification
systems. Moreover, the list of criminal offences provided in an annex to this Regulation is based on the 32 criminal
offences listed in the Council Framework Decision 2002/584/JHA (18), taking into account that some of those
offences are, in practice, likely to be more relevant than others, in that the recourse to ‘real-time’ remote biometric
identification could, foreseeably, be necessary and proportionate to highly varying degrees for the practical pursuit
of the localisation or identification of a perpetrator or suspect of the different criminal offences listed and having
regard to the likely differences in the seriousness, probability and scale of the harm or possible negative
consequences. An imminent threat to life or the physical safety of natural persons could also result from a serious
disruption of critical infrastructure, as defined in Article 2, point (4) of Directive (EU) 2022/2557 of the European
Parliament and of the Council (19), where the disruption or destruction of such critical infrastructure would result in
an imminent threat to life or the physical safety of a person, including through serious harm to the provision of basic
supplies to the population or to the exercise of the core function of the State.
Show original text
The destruction of
critical infrastructure poses an immediate threat to people's lives and safety, especially if it disrupts
basic supplies or the essential functions of the State. This
Regulation allows
law enforcement, border control, immigration, and
asylum authorities to conduct
identity checks on individuals present, following
Union and national laws. These authorities can use information systems to identify individuals who refuse to provide their identity or cannot do so due to circumstances like an accident or medical condition, without needing prior approval. To ensure responsible use of these systems, specific factors must be considered, including the nature of the situation and its impact on the rights of those involved. Additionally, 'real-time'
remote biometric identification in public spaces for
law enforcement should only be used to confirm the identity of a targeted individual and must be limited in time, location, and scope, based on evidence of threats or the identity of victims or perpetrators.
or destruction of such critical infrastructure would result in
an imminent threat to life or the physical safety of a person, including through serious harm to the provision of basic
supplies to the population or to the exercise of the core function of the State. In addition, this Regulation should
preserve the ability for law enforcement, border control, immigration or asylum authorities to carry out identity
checks in the presence of the person concerned in accordance with the conditions set out in Union and national law
for such checks. In particular, law enforcement, border control, immigration or asylum authorities should be able to
use information systems, in accordance with Union or national law, to identify persons who, during an identity
check, either refuse to be identified or are unable to state or prove their identity, without being required by this
Regulation to obtain prior authorisation. This could be, for example, a person involved in a crime, being unwilling,
or unable due to an accident or a medical condition, to disclose their identity to law enforcement authorities.
(34)
In order to ensure that those systems are used in a responsible and proportionate manner, it is also important to
establish that, in each of those exhaustively listed and narrowly defined situations, certain elements should be taken
into account, in particular as regards the nature of the situation giving rise to the request and the consequences of
the use for the rights and freedoms of all persons concerned and the safeguards and conditions provided for with the
use. In addition, the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the
purpose of law enforcement should be deployed only to confirm the specifically targeted individual’s identity and
should be limited to what is strictly necessary concerning the period of time, as well as the geographic and personal
scope, having regard in particular to the evidence or indications regarding the threats, the victims or perpetrator.
Show original text
The identity of the targeted individual should only be collected as necessary, considering the time period, location, and personal details, especially in relation to any threats, victims, or perpetrators. The use of
real-time remote biometric identification systems in public spaces must be approved by
law enforcement authorities after conducting a
fundamental rights impact assessment. Unless stated otherwise in this
regulation, these systems must also be registered in a designated database. Each use of these systems for
law enforcement must receive explicit authorization from a judicial or
independent administrative authority in a
Member State, and this approval should generally be obtained before using the
AI system to identify individuals. Exceptions can be made in
urgent situations where it is impossible to get prior authorization. In such cases, the use of the
AI system must be limited to what is absolutely necessary and must follow appropriate
safeguards as defined by
national law. The
law enforcement authority must request authorization as soon as possible, explaining why it could not be obtained earlier, and must do so within 24 hours.
the specifically targeted individual’s identity and
should be limited to what is strictly necessary concerning the period of time, as well as the geographic and personal
scope, having regard in particular to the evidence or indications regarding the threats, the victims or perpetrator. The
use of the real-time remote biometric identification system in publicly accessible spaces should be authorised only if
the relevant law enforcement authority has completed a fundamental rights impact assessment and, unless provided
otherwise in this Regulation, has registered the system in the database as set out in this Regulation. The reference
database of persons should be appropriate for each use case in each of the situations mentioned above.
(35)
Each use of a ‘real-time’ remote biometric identification system in publicly accessible spaces for the purpose of law
enforcement should be subject to an express and specific authorisation by a judicial authority or by an independent
administrative authority of a Member State whose decision is binding. Such authorisation should, in principle, be
obtained prior to the use of the AI system with a view to identifying a person or persons. Exceptions to that rule
should be allowed in duly justified situations on grounds of urgency, namely in situations where the need to use the
systems concerned is such as to make it effectively and objectively impossible to obtain an authorisation before
commencing the use of the AI system. In such situations of urgency, the use of the AI system should be restricted to
the absolute minimum necessary and should be subject to appropriate safeguards and conditions, as determined in
national law and specified in the context of each individual urgent use case by the law enforcement authority itself.
In addition, the law enforcement authority should in such situations request such authorisation while providing the
reasons for not having been able to request it earlier, without undue delay and at the latest within 24 hours.
Show original text
The
law enforcement authority must request authorization for using
real-time biometric identification systems as soon as possible, and no later than 24 hours after the initial use. They should explain why they couldn't request it earlier. If the authorization is denied, the use of the biometric system must stop immediately, and all related
data must be deleted. This
data includes information collected by the
AI system and any results produced from its use, but it does not include
data obtained legally under other laws. Additionally, no decisions that negatively affect a person can be made based solely on the results from the biometric identification system. To ensure compliance with this
regulation and national laws, the relevant
market surveillance authority and
national data protection authority must be informed of each use of the biometric identification system.
the law enforcement authority itself.
In addition, the law enforcement authority should in such situations request such authorisation while providing the
reasons for not having been able to request it earlier, without undue delay and at the latest within 24 hours. If such
an authorisation is rejected, the use of real-time biometric identification systems linked to that authorisation should
cease with immediate effect and all the data related to such use should be discarded and deleted. Such data includes
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(18)
Council Framework Decision 2002/584/JHA of 13 June 2002 on the European arrest warrant and the surrender procedures
between Member States (OJ L 190, 18.7.2002, p. 1).
(19)
Directive (EU) 2022/2557 of the European Parliament and of the Council of 14 December 2022 on the resilience of critical entities
and repealing Council Directive 2008/114/EC (OJ L 333, 27.12.2022, p. 164).
input data directly acquired by an AI system in the course of the use of such system as well as the results and outputs
of the use linked to that authorisation. It should not include input that is legally acquired in accordance with another
Union or national law. In any case, no decision producing an adverse legal effect on a person should be taken based
solely on the output of the remote biometric identification system.
(36)
In order to carry out their tasks in accordance with the requirements set out in this Regulation as well as in national
rules, the relevant market surveillance authority and the national data protection authority should be notified of each
use of the real-time biometric identification system.
Show original text
to carry out their tasks in accordance with the requirements set out in this Regulation as well as in national
rules, the relevant market surveillance authority and the national data protection authority should be notified of each
use of the real-time biometric identification system. Market surveillance authorities and the national data protection
authorities that have been notified should submit to the Commission an annual report on the use of real-time
biometric identification systems.
(37)
Furthermore, it is appropriate to provide, within the exhaustive framework set by this Regulation that such use in
the territory of a Member State in accordance with this Regulation should only be possible where and in as far as the
Member State concerned has decided to expressly provide for the possibility to authorise such use in its detailed rules
of national law. Consequently, Member States remain free under this Regulation not to provide for such a possibility
at all or to only provide for such a possibility in respect of some of the objectives capable of justifying authorised use
identified in this Regulation. Such national rules should be notified to the Commission within 30 days of their
adoption.
(38)
The use of AI systems for real-time remote biometric identification of natural persons in publicly accessible spaces
for the purpose of law enforcement necessarily involves the processing of biometric data. The rules of this
Regulation that prohibit, subject to certain exceptions, such use, which are based on Article 16 TFEU, should apply
as lex specialis in respect of the rules on the processing of biometric data contained in Article 10 of Directive (EU)
2016/680, thus regulating such use and the processing of biometric data involved in an exhaustive manner.
Show original text
as lex specialis in respect of the rules on the processing of biometric data contained in Article 10 of Directive (EU)
2016/680, thus regulating such use and the processing of biometric data involved in an exhaustive manner.
Therefore, such use and processing should be possible only in as far as it is compatible with the framework set by
this Regulation, without there being scope, outside that framework, for the competent authorities, where they act for
purpose of law enforcement, to use such systems and process such data in connection thereto on the grounds listed
in Article 10 of Directive (EU) 2016/680. In that context, this Regulation is not intended to provide the legal basis
for the processing of personal data under Article 8 of Directive (EU) 2016/680. However, the use of real-time remote
biometric identification systems in publicly accessible spaces for purposes other than law enforcement, including by
competent authorities, should not be covered by the specific framework regarding such use for the purpose of law
enforcement set by this Regulation. Such use for purposes other than law enforcement should therefore not be
subject to the requirement of an authorisation under this Regulation and the applicable detailed rules of national law
that may give effect to that authorisation.
(39)
Any processing of biometric data and other personal data involved in the use of AI systems for biometric
identification, other than in connection to the use of real-time remote biometric identification systems in publicly
accessible spaces for the purpose of law enforcement as regulated by this Regulation, should continue to comply
with all requirements resulting from Article 10 of Directive (EU) 2016/680.
Show original text
use of real-time remote biometric identification systems in publicly
accessible spaces for the purpose of law enforcement as regulated by this Regulation, should continue to comply
with all requirements resulting from Article 10 of Directive (EU) 2016/680. For purposes other than law
enforcement, Article 9(1) of Regulation (EU) 2016/679 and Article 10(1) of Regulation (EU) 2018/1725 prohibit the
processing of biometric data subject to limited exceptions as provided in those Articles. In the application of Article
9(1) of Regulation (EU) 2016/679, the use of remote biometric identification for purposes other than law
enforcement has already been subject to prohibition decisions by national data protection authorities.
(40)
In accordance with Article 6a of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the
area of freedom, security and justice, as annexed to the TEU and to the TFEU, Ireland is not bound by the rules laid
down in Article 5(1), first subparagraph, point (g), to the extent it applies to the use of biometric categorisation
systems for activities in the field of police cooperation and judicial cooperation in criminal matters, Article 5(1), first
subparagraph, point (d), to the extent it applies to the use of AI systems covered by that provision, Article 5(1), first
subparagraph, point (h), Article 5(2) to (6) and Article 26(10) of this Regulation adopted on the basis of Article 16
TFEU which relate to the processing of personal data by the Member States when carrying out activities falling
within the scope of Chapter 4 or Chapter 5 of Title V of Part Three of the TFEU, where Ireland is not bound by the
rules governing the forms of judicial cooperation in criminal
Show original text
Member States are not required to follow certain judicial and police cooperation rules when
Ireland is involved in activities related to Chapters 4 or 5 of Title V of Part Three of the
TFEU. Additionally, according to Articles 2 and 2a of
Protocol No 22 regarding Denmark, Denmark is not obligated to comply with specific rules about biometric categorization systems and
AI systems in police and judicial cooperation, as outlined in
Article 5(1) of the
Regulation adopted under
Article 16 TFEU. Furthermore, it is important to uphold the
presumption of innocence, meaning individuals in the
Union should be judged based on their actual behavior.
by the Member States when carrying out activities falling
within the scope of Chapter 4 or Chapter 5 of Title V of Part Three of the TFEU, where Ireland is not bound by the
rules governing the forms of judicial cooperation in criminal matters or police cooperation which require
compliance with the provisions laid down on the basis of Article 16 TFEU.
(41)
In accordance with Articles 2 and 2a of Protocol No 22 on the position of Denmark, annexed to the TEU and to the
TFEU, Denmark is not bound by rules laid down in Article 5(1), first subparagraph, point (g), to the extent it applies
to the use of biometric categorisation systems for activities in the field of police cooperation and judicial cooperation
in criminal matters, Article 5(1), first subparagraph, point (d), to the extent it applies to the use of AI systems
covered by that provision, Article 5(1), first subparagraph, point (h), (2) to (6) and Article 26(10) of this Regulation
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adopted on the basis of Article 16 TFEU, or subject to their application, which relate to the processing of personal
data by the Member States when carrying out activities falling within the scope of Chapter 4 or Chapter 5 of
Title V of Part Three of the TFEU.
(42)
In line with the presumption of innocence, natural persons in the Union should always be judged on their actual
behaviour.
Show original text
Chapter 4 and Chapter 5 of Title V of Part Three of the
TFEU outline important guidelines. According to the principle of
presumption of innocence, individuals in the
European Union should be judged based on their actual actions, not on
AI predictions about their behavior derived from profiling or personal traits like nationality, birthplace, residence, number of children, debt level, or car type. There must be reasonable suspicion based on objective facts and human evaluation before judging someone. Therefore, risk assessments predicting criminal behavior based solely on profiling should be banned. However, this ban does not apply to
risk analytics that do not involve profiling individuals, such as
AI systems assessing the likelihood of financial fraud based on suspicious transactions or tools predicting the location of illegal goods based on known trafficking routes. Additionally, the use of
AI systems that create or enhance
facial recognition databases by indiscriminately collecting facial images from the internet or CCTV should be prohibited, as this contributes to mass surveillance and can violate
fundamental rights, including privacy. There are also significant concerns about the reliability of
AI systems designed to identify or interpret emotions, as emotional expressions can vary widely across different cultures and contexts, and even within the same person.
the scope of Chapter 4 or Chapter 5 of
Title V of Part Three of the TFEU.
(42)
In line with the presumption of innocence, natural persons in the Union should always be judged on their actual
behaviour. Natural persons should never be judged on AI-predicted behaviour based solely on their profiling,
personality traits or characteristics, such as nationality, place of birth, place of residence, number of children, level of
debt or type of car, without a reasonable suspicion of that person being involved in a criminal activity based on
objective verifiable facts and without human assessment thereof. Therefore, risk assessments carried out with regard
to natural persons in order to assess the likelihood of their offending or to predict the occurrence of an actual or
potential criminal offence based solely on profiling them or on assessing their personality traits and characteristics
should be prohibited. In any case, that prohibition does not refer to or touch upon risk analytics that are not based
on the profiling of individuals or on the personality traits and characteristics of individuals, such as AI systems using
risk analytics to assess the likelihood of financial fraud by undertakings on the basis of suspicious transactions or
risk analytic tools to predict the likelihood of the localisation of narcotics or illicit goods by customs authorities, for
example on the basis of known trafficking routes.
(43)
The placing on the market, the putting into service for that specific purpose, or the use of AI systems that create or
expand facial recognition databases through the untargeted scraping of facial images from the internet or CCTV
footage, should be prohibited because that practice adds to the feeling of mass surveillance and can lead to gross
violations of fundamental rights, including the right to privacy.
(44)
There are serious concerns about the scientific basis of AI systems aiming to identify or infer emotions, particularly
as expression of emotions vary considerably across cultures and situations, and even within a single individual.
Show original text
There are significant concerns about the scientific validity of
AI systems that try to identify or infer emotions. This is because emotional expressions can differ greatly across cultures, situations, and even within the same person. Key issues with these systems include their unreliability, lack of precision, and limited applicability. As a result,
AI systems that use
biometric data to determine emotions or intentions could lead to
discrimination and violate individuals' rights and freedoms. In contexts like work or education, where there is often a power imbalance, these systems could result in unfair treatment of certain individuals or groups. Therefore,
AI systems designed to detect emotional states in workplace or educational settings should be banned. However, this ban does not apply to
AI systems intended for medical or safety purposes, such as those used in therapy. Additionally, practices that are already prohibited by EU laws, including
data protection, non-
discrimination, consumer protection, and competition laws, will not be affected by this
regulation.
High-risk AI systems can only be sold, used, or implemented in the EU if they meet specific mandatory requirements to ensure they do not pose unacceptable risks to important public interests protected by EU law.
fundamental rights, including the right to privacy.
(44)
There are serious concerns about the scientific basis of AI systems aiming to identify or infer emotions, particularly
as expression of emotions vary considerably across cultures and situations, and even within a single individual.
Among the key shortcomings of such systems are the limited reliability, the lack of specificity and the limited
generalisability. Therefore, AI systems identifying or inferring emotions or intentions of natural persons on the basis
of their biometric data may lead to discriminatory outcomes and can be intrusive to the rights and freedoms of the
concerned persons. Considering the imbalance of power in the context of work or education, combined with the
intrusive nature of these systems, such systems could lead to detrimental or unfavourable treatment of certain
natural persons or whole groups thereof. Therefore, the placing on the market, the putting into service, or the use of
AI systems intended to be used to detect the emotional state of individuals in situations related to the workplace and
education should be prohibited. That prohibition should not cover AI systems placed on the market strictly for
medical or safety reasons, such as systems intended for therapeutical use.
(45)
Practices that are prohibited by Union law, including data protection law, non-discrimination law, consumer
protection law, and competition law, should not be affected by this Regulation.
(46)
High-risk AI systems should only be placed on the Union market, put into service or used if they comply with
certain mandatory requirements. Those requirements should ensure that high-risk AI systems available in the Union
or whose output is otherwise used in the Union do not pose unacceptable risks to important Union public interests
as recognised and protected by Union law.
Show original text
Certain mandatory requirements must be followed to ensure that
high-risk AI systems used in the
European Union do not pose unacceptable risks to important public interests protected by EU law. According to the
New Legislative Framework, as explained in the
Commission's notice 'The Blue Guide on the implementation of EU product rules 2022', multiple EU laws can apply to a single product. This includes Regulations (EU) 2017/745 and (EU)
2017/746, as well as
Directive 2006/42/EC, since a product can be made available or put into service under more than one legal act.
comply with
certain mandatory requirements. Those requirements should ensure that high-risk AI systems available in the Union
or whose output is otherwise used in the Union do not pose unacceptable risks to important Union public interests
as recognised and protected by Union law. On the basis of the New Legislative Framework, as clarified in the
Commission notice ‘The “Blue Guide” on the implementation of EU product rules 2022’ (20), the general rule is that
more than one legal act of Union harmonisation legislation, such as Regulations (EU) 2017/745 (21) and (EU)
2017/746 (22) of the European Parliament and of the Council or Directive 2006/42/EC of the European Parliament
and of the Council (23), may be applicable to one product, since the making available or putting into service can take
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(20)
OJ C 247, 29.6.2022, p. 1.
(21)
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive
2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and
93/42/EEC (OJ L 117, 5.5.2017, p. 1).
Show original text
Regulation (EC) No 1223/2009, which replaced
Council Directives 90/385/EEC and 93/42/EEC, was published in the Official Journal on May 5, 2017. Additionally,
Regulation (EU) 2017/746, concerning
in vitro diagnostic medical devices, replaced
Directive 98/79/EC and
Commission Decision 2010/227/EU, also published on May 5, 2017. Furthermore,
Directive 2006/42/EC, which addresses
machinery and amends Directive 95/16/EC, was published on June 9, 2006. Products can only be placed on the market if they comply with all relevant EU harmonization laws. To reduce administrative burdens and costs,
providers of products containing
high-risk AI systems should have the flexibility to decide how to meet compliance requirements effectively.
High-risk AI systems are those that could significantly harm the health, safety, and
fundamental rights of individuals in the EU, and this limitation aims to minimize any negative impact on international trade. It's important to note that
AI systems can pose risks to
health and safety, especially when they are part of
safety components in products.
EC) No 1223/2009 and repealing Council Directives 90/385/EEC and
93/42/EEC (OJ L 117, 5.5.2017, p. 1).
(22)
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and
repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).
(23)
Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive
95/16/EC (OJ L 157, 9.6.2006, p. 24).
place only when the product complies with all applicable Union harmonisation legislation. To ensure consistency
and avoid unnecessary administrative burdens or costs, providers of a product that contains one or more high-risk
AI systems, to which the requirements of this Regulation and of the Union harmonisation legislation listed in an
annex to this Regulation apply, should have flexibility with regard to operational decisions on how to ensure
compliance of a product that contains one or more AI systems with all applicable requirements of the Union
harmonisation legislation in an optimal manner. AI systems identified as high-risk should be limited to those that
have a significant harmful impact on the health, safety and fundamental rights of persons in the Union and such
limitation should minimise any potential restriction to international trade.
(47)
AI systems could have an adverse impact on the health and safety of persons, in particular when such systems
operate as safety components of products.
Show original text
The
Union aims to limit restrictions on international trade while ensuring the safety and health of its citizens.
AI systems can pose risks, especially when they are part of safety features in products. To support the free movement of safe products in the market, it is crucial to address and reduce any safety risks associated with digital components, including
AI. For example, autonomous robots used in manufacturing or personal care must operate safely in complex environments. In healthcare, advanced diagnostic systems must be reliable and accurate due to the high stakes involved. Additionally, when determining if an
AI system is high risk, it is important to consider its potential negative effects on
fundamental rights protected by the
Charter. These rights include human dignity, privacy,
data protection, freedom of expression, assembly, and association, non-
discrimination, education, consumer protection, workers' rights, rights of persons with disabilities, gender equality,
intellectual property rights, the right to a
fair trial, and good administration.
of persons in the Union and such
limitation should minimise any potential restriction to international trade.
(47)
AI systems could have an adverse impact on the health and safety of persons, in particular when such systems
operate as safety components of products. Consistent with the objectives of Union harmonisation legislation to
facilitate the free movement of products in the internal market and to ensure that only safe and otherwise compliant
products find their way into the market, it is important that the safety risks that may be generated by a product as
a whole due to its digital components, including AI systems, are duly prevented and mitigated. For instance,
increasingly autonomous robots, whether in the context of manufacturing or personal assistance and care should be
able to safely operate and performs their functions in complex environments. Similarly, in the health sector where
the stakes for life and health are particularly high, increasingly sophisticated diagnostics systems and systems
supporting human decisions should be reliable and accurate.
(48)
The extent of the adverse impact caused by the AI system on the fundamental rights protected by the Charter is of
particular relevance when classifying an AI system as high risk. Those rights include the right to human dignity,
respect for private and family life, protection of personal data, freedom of expression and information, freedom of
assembly and of association, the right to non-discrimination, the right to education, consumer protection, workers’
rights, the rights of persons with disabilities, gender equality, intellectual property rights, the right to an effective
remedy and to a fair trial, the right of defence and the presumption of innocence, and the right to good
administration.
Show original text
This text discusses various rights, including the rights of people with disabilities, gender equality,
intellectual property rights, the right to a
fair trial, the right to defend oneself, the
presumption of innocence, and the right to good administration. It also emphasizes that children have specific rights outlined in
Article 24 of the
Charter and the United Nations Convention on the Rights of the Child (UNCRC). These rights, further detailed in UNCRC General Comment No. 25 regarding the digital environment, recognize children's vulnerabilities and the need for protection and care for their well-being. Additionally, the
Charter includes the fundamental right to a high level of environmental protection, which should be considered when evaluating the potential harm caused by
AI systems, especially concerning
health and safety. The text also mentions
high-risk AI systems that are part of products or systems regulated by various
European Union regulations and directives, including
Regulation (EC) No. 300/2008,
Regulation (EU) No. 167/2013,
Regulation (EU) No. 168/2013,
Directive 2014/90/EU,
Directive (EU) 2016/797,
Regulation (EU) 2018/858, and
Regulation (EU) 2018/1139.
’
rights, the rights of persons with disabilities, gender equality, intellectual property rights, the right to an effective
remedy and to a fair trial, the right of defence and the presumption of innocence, and the right to good
administration. In addition to those rights, it is important to highlight the fact that children have specific rights as
enshrined in Article 24 of the Charter and in the United Nations Convention on the Rights of the Child, further
developed in the UNCRC General Comment No 25 as regards the digital environment, both of which require
consideration of the children’s vulnerabilities and provision of such protection and care as necessary for their
well-being. The fundamental right to a high level of environmental protection enshrined in the Charter and
implemented in Union policies should also be considered when assessing the severity of the harm that an AI system
can cause, including in relation to the health and safety of persons.
(49)
As regards high-risk AI systems that are safety components of products or systems, or which are themselves
products or systems falling within the scope of Regulation (EC) No 300/2008 of the European Parliament and of the
Council (24), Regulation (EU) No 167/2013 of the European Parliament and of the Council (25), Regulation
(EU) No 168/2013 of the European Parliament and of the Council (26), Directive 2014/90/EU of the European
Parliament and of the Council (27), Directive (EU) 2016/797 of the European Parliament and of the Council (28),
Regulation (EU) 2018/858 of the European Parliament and of the Council (29), Regulation (EU) 2018/1139 of the
OJ L, 12.7.
Show original text
This text references several regulations and directives from the
European Parliament and Council. Key documents include:
1.
Regulation (EU) 2018/858,
2.
Regulation (EU) 2018/1139,
3.
Regulation (EC) No 300/2008, which establishes common rules for civil aviation security and replaces
Regulation (EC) No 2320/2002,
4.
Regulation (EU) No 167/2013, concerning the approval and market surveillance of agricultural and forestry vehicles,
5.
Regulation (EU) No 168/2013, related to the approval and market surveillance of two- or three-wheel vehicles and quadricycles,
6.
Directive 2014/90/EU, which addresses marine equipment and replaces
Council Directive 96/98/EC,
7.
Directive (EU) 2016/797, focusing on the interoperability of the rail system within the EU.
of the Council (28),
Regulation (EU) 2018/858 of the European Parliament and of the Council (29), Regulation (EU) 2018/1139 of the
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(24)
Regulation (EC) No 300/2008 of the European Parliament and of the Council of 11 March 2008 on common rules in the field of
civil aviation security and repealing Regulation (EC) No 2320/2002 (OJ L 97, 9.4.2008, p. 72).
(25)
Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market
surveillance of agricultural and forestry vehicles (OJ L 60, 2.3.2013, p. 1).
(26)
Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market
surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52).
(27)
Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council
Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146).
(28)
Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system
within the European Union (OJ L 138, 26.5.
Show original text
Directive (EU) 2016/797, issued by the
European Parliament and Council on May 11, 2016, focuses on making the rail system in the
European Union interoperable (Official Journal L 138, 26.5.2016, p. 44).
Regulation (EU) 2018/858, also from the
European Parliament and Council, was enacted on May 30, 2018. It deals with the approval and market monitoring of motor vehicles, trailers, and their components, while updating previous regulations (Official Journal L 151, 14.6.2018, p. 1). Additionally,
Regulation (EU) 2019/2144 requires amendments to ensure that the
European Commission considers the specific technical and regulatory needs of each sector. This is to ensure compliance with the mandatory requirements for
high-risk AI systems outlined in this
Regulation, without disrupting existing governance and enforcement mechanisms. Furthermore,
AI systems that are
safety components of products or are products themselves will be classified as high-risk if they are
subject to
conformity assessment by a third-party body under relevant EU harmonization legislation.
)
Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system
within the European Union (OJ L 138, 26.5.2016, p. 44).
(29)
Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance
of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending
Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1).
European Parliament and of the Council (30), and Regulation (EU) 2019/2144 of the European Parliament and of the
Council (31), it is appropriate to amend those acts to ensure that the Commission takes into account, on the basis of
the technical and regulatory specificities of each sector, and without interfering with existing governance, conformity
assessment and enforcement mechanisms and authorities established therein, the mandatory requirements for
high-risk AI systems laid down in this Regulation when adopting any relevant delegated or implementing acts on the
basis of those acts.
(50)
As regards AI systems that are safety components of products, or which are themselves products, falling within the
scope of certain Union harmonisation legislation listed in an annex to this Regulation, it is appropriate to classify
them as high-risk under this Regulation if the product concerned undergoes the conformity assessment procedure
with a third-party conformity assessment body pursuant to that relevant Union harmonisation legislation.
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Products listed in the annex of this
Regulation are classified as high-risk if they go through a
conformity assessment with a third-party body according to relevant EU harmonization laws. These products include
machinery,
toys, lifts, equipment for explosive environments, radio equipment, pressure equipment, recreational craft, cableway systems, gas-burning appliances,
medical devices, in vitro diagnostic devices, and automotive and aviation products.
However, classifying an
AI system as high-risk under this
Regulation does not automatically mean that the product it is part of, or the
AI system itself, is considered high-risk according to the relevant EU laws. This is particularly true for Regulations (EU) 2017/745 and (EU)
2017/746, which allow for third-party assessments for medium and high-risk products.
For stand-alone
high-risk AI systems, which are not
safety components of other products, they should be classified as high-risk if their intended use poses a significant risk to health, safety, or
fundamental rights. This classification considers both the severity and likelihood of potential harm and applies to specific areas defined in this
Regulation.
isation legislation listed in an annex to this Regulation, it is appropriate to classify
them as high-risk under this Regulation if the product concerned undergoes the conformity assessment procedure
with a third-party conformity assessment body pursuant to that relevant Union harmonisation legislation. In
particular, such products are machinery, toys, lifts, equipment and protective systems intended for use in potentially
explosive atmospheres, radio equipment, pressure equipment, recreational craft equipment, cableway installations,
appliances burning gaseous fuels, medical devices, in vitro diagnostic medical devices, automotive and aviation.
(51)
The classification of an AI system as high-risk pursuant to this Regulation should not necessarily mean that the
product whose safety component is the AI system, or the AI system itself as a product, is considered to be high-risk
under the criteria established in the relevant Union harmonisation legislation that applies to the product. This is, in
particular, the case for Regulations (EU) 2017/745 and (EU) 2017/746, where a third-party conformity assessment is
provided for medium-risk and high-risk products.
(52)
As regards stand-alone AI systems, namely high-risk AI systems other than those that are safety components of
products, or that are themselves products, it is appropriate to classify them as high-risk if, in light of their intended
purpose, they pose a high risk of harm to the health and safety or the fundamental rights of persons, taking into
account both the severity of the possible harm and its probability of occurrence and they are used in a number of
specifically pre-defined areas specified in this Regulation.
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This
regulation assesses the risk of harm to people's health, safety, or
fundamental rights by considering both how severe the potential harm could be and how likely it is to happen. It focuses on specific areas defined in the
regulation. The identification of
high-risk AI systems follows a set methodology and criteria, which will also apply to any future updates to the list of
high-risk AI systems. The
Commission has the authority to make these updates through delegated acts to keep pace with rapid technological advancements and changes in
AI usage.
It's important to note that some
AI systems in these defined areas may not pose a significant risk to legal interests if they do not significantly affect decision-making. For this
regulation, an
AI system is considered to not materially influence decision-making if it does not impact the substance or outcome of decisions, whether made by humans or automated processes. Examples of such
AI systems include those that perform narrow tasks, like converting unstructured
data into structured
data, classifying documents, or identifying duplicate applications. These limited tasks carry minimal risks, even when used in high-risk contexts outlined in the
regulation.
risk of harm to the health and safety or the fundamental rights of persons, taking into
account both the severity of the possible harm and its probability of occurrence and they are used in a number of
specifically pre-defined areas specified in this Regulation. The identification of those systems is based on the same
methodology and criteria envisaged also for any future amendments of the list of high-risk AI systems that the
Commission should be empowered to adopt, via delegated acts, to take into account the rapid pace of technological
development, as well as the potential changes in the use of AI systems.
(53)
It is also important to clarify that there may be specific cases in which AI systems referred to in pre-defined areas
specified in this Regulation do not lead to a significant risk of harm to the legal interests protected under those areas
because they do not materially influence the decision-making or do not harm those interests substantially. For the
purposes of this Regulation, an AI system that does not materially influence the outcome of decision-making should
be understood to be an AI system that does not have an impact on the substance, and thereby the outcome, of
decision-making, whether human or automated. An AI system that does not materially influence the outcome of
decision-making could include situations in which one or more of the following conditions are fulfilled. The first
such condition should be that the AI system is intended to perform a narrow procedural task, such as an AI system
that transforms unstructured data into structured data, an AI system that classifies incoming documents into
categories or an AI system that is used to detect duplicates among a large number of applications. Those tasks are of
such narrow and limited nature that they pose only limited risks which are not increased through the use of an AI
system in a context that is listed as a high-risk use in an annex to this Regulation. The second condition should be
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There are only limited risks associated with using an
AI system in high-risk situations as defined in an annex to this
Regulation. The second condition is outlined in
Regulation (EU) 2018/1139, which was established by the
European Parliament and Council on July 4, 2018. This
regulation sets common rules for civil aviation and creates the
European Union Aviation Safety Agency. It also amends several previous regulations and directives related to aviation safety. Additionally,
Regulation (EU) 2019/2144, enacted on November 27, 2019, addresses type-approval requirements for motor vehicles and their trailers, focusing on general safety and the protection of vehicle occupants and vulnerable road
users. This
regulation also amends and repeals earlier regulations concerning vehicle safety.
only limited risks which are not increased through the use of an AI
system in a context that is listed as a high-risk use in an annex to this Regulation. The second condition should be
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(30)
Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil
aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC)
No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament
and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the
Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1).
(31)
Regulation (EU) 2019/2144 of the European Parliament and of the Council of 27 November 2019 on type-approval requirements
for motor vehicles and their trailers, and systems, components and separate technical units intended for such vehicles, as regards
their general safety and the protection of vehicle occupants and vulnerable road users, amending Regulation (EU) 2018/858 of the
European Parliament and of the Council and repealing Regulations (EC) No 78/2009, (EC) No 79/2009 and (EC) No 661/2009 of
the European Parliament and of the Council
Show original text
The
European Parliament and the
Council have repealed several regulations, including Regulations (EC) No 78/2009, (EC) No 79/2009, and (EC) No 661/2009, as well as
Commission Regulations (EC) No 631/2009, (EU) No 406/2010, (EU) No 672/2010, (EU) No 1003/2010, (EU) No 1005/2010, (EU) No 1008/2010, (EU) No 1009/2010, (EU) No 19/2011, (EU) No 109/2011, (EU) No 458/2011, (EU) No 65/2012, (EU) No 130/2012, (EU) No 347/2012, (EU) No 351/2012, (EU) No 1230/2012, and (EU) 2015/166 (
OJ L 325, 16.12.2019, p. 1).
The
AI system's role is to enhance the results of tasks previously done by humans, particularly for high-risk applications listed in an annex of this
Regulation. This means the
AI adds an extra layer to human work, which reduces risk. For example,
AI can improve the language in documents by refining the professional tone, academic style, or aligning the text with specific brand messaging. Additionally, the
AI system should be designed to identify patterns in decision-making or notice deviations from past decisions.
the
European Parliament and of the Council and repealing Regulations (EC) No 78/2009, (EC) No 79/2009 and (EC) No 661/2009 of
the European Parliament and of the Council and Commission Regulations (EC) No 631/2009, (EU) No 406/2010, (EU)
No 672/2010, (EU) No 1003/2010, (EU) No 1005/2010, (EU) No 1008/2010, (EU) No 1009/2010, (EU) No 19/2011, (EU)
No 109/2011, (EU) No 458/2011, (EU) No 65/2012, (EU) No 130/2012, (EU) No 347/2012, (EU) No 351/2012, (EU)
No 1230/2012 and (EU) 2015/166 (OJ L 325, 16.12.2019, p. 1).
that the task performed by the AI system is intended to improve the result of a previously completed human activity
that may be relevant for the purposes of the high-risk uses listed in an annex to this Regulation. Considering those
characteristics, the AI system provides only an additional layer to a human activity with consequently lowered risk.
That condition would, for example, apply to AI systems that are intended to improve the language used in previously
drafted documents, for example in relation to professional tone, academic style of language or by aligning text to
a certain brand messaging. The third condition should be that the AI system is intended to detect decision-making
patterns or deviations from prior decision-making patterns.
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AI systems should meet certain conditions to ensure they are safe and effective. First, they should maintain a professional tone and academic language, and align with specific brand messaging. Second, these systems should be designed to identify patterns in decision-making or any changes from previous patterns. This reduces risk because the
AI is used after a human assessment, which it does not replace or influence without proper review. For example, an
AI can analyze a teacher's grading patterns to identify any inconsistencies. Third, the
AI should only perform tasks that prepare for an assessment relevant to specific regulations, minimizing the risk of its output affecting the final assessment. This includes smart file handling solutions like indexing, searching, and translating documents. Lastly,
AI systems used in high-risk scenarios, as listed in the regulations, can pose significant risks to health, safety, or
fundamental rights, especially if they involve profiling as defined in EU regulations.
, for example in relation to professional tone, academic style of language or by aligning text to
a certain brand messaging. The third condition should be that the AI system is intended to detect decision-making
patterns or deviations from prior decision-making patterns. The risk would be lowered because the use of the AI
system follows a previously completed human assessment which it is not meant to replace or influence, without
proper human review. Such AI systems include for instance those that, given a certain grading pattern of a teacher,
can be used to check ex post whether the teacher may have deviated from the grading pattern so as to flag potential
inconsistencies or anomalies. The fourth condition should be that the AI system is intended to perform a task that is
only preparatory to an assessment relevant for the purposes of the AI systems listed in an annex to this Regulation,
thus making the possible impact of the output of the system very low in terms of representing a risk for the
assessment to follow. That condition covers, inter alia, smart solutions for file handling, which include various
functions from indexing, searching, text and speech processing or linking data to other data sources, or AI systems
used for translation of initial documents. In any case, AI systems used in high-risk use-cases listed in an annex to this
Regulation should be considered to pose significant risks of harm to the health, safety or fundamental rights if the AI
system implies profiling within the meaning of Article 4, point (4) of Regulation (EU) 2016/679 or Article 3,
point (4) of Directive (EU) 2016/680 or Article 3, point (5) of Regulation (EU) 2018/1725.
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Regulation (EU) 2016/679,
Article 3, point (4) of
Directive (EU) 2016/680, and
Article 3, point (5) of
Regulation (EU) 2018/1725 require that if a
provider believes their
AI system is not high-risk, they must document their assessment before the system is sold or used. This documentation must be available to
national authorities if requested. Additionally, the
provider must register the
AI system in the
EU database created by this
Regulation. To help with the practical application of these rules, the
Commission will provide guidelines, after consulting the
Board, that include examples of both high-risk and non-
high-risk AI systems.
Biometric data is considered a special type of
personal data, and many critical uses of biometric systems are classified as high-risk, as long as they comply with relevant EU and national laws.
AI systems used for
remote biometric identification can produce inaccurate results, leading to bias and
discrimination based on age, ethnicity, race, sex, or disabilities. Therefore, these
remote biometric identification systems are classified as high-risk due to the potential dangers they pose.
Regulation (EU) 2016/679 or Article 3,
point (4) of Directive (EU) 2016/680 or Article 3, point (5) of Regulation (EU) 2018/1725. To ensure traceability
and transparency, a provider who considers that an AI system is not high-risk on the basis of the conditions referred
to above should draw up documentation of the assessment before that system is placed on the market or put into
service and should provide that documentation to national competent authorities upon request. Such a provider
should be obliged to register the AI system in the EU database established under this Regulation. With a view to
providing further guidance for the practical implementation of the conditions under which the AI systems listed in
an annex to this Regulation are, on an exceptional basis, non-high-risk, the Commission should, after consulting the
Board, provide guidelines specifying that practical implementation, completed by a comprehensive list of practical
examples of use cases of AI systems that are high-risk and use cases that are not.
(54)
As biometric data constitutes a special category of personal data, it is appropriate to classify as high-risk several
critical-use cases of biometric systems, insofar as their use is permitted under relevant Union and national law.
Technical inaccuracies of AI systems intended for the remote biometric identification of natural persons can lead to
biased results and entail discriminatory effects. The risk of such biased results and discriminatory effects is
particularly relevant with regard to age, ethnicity, race, sex or disabilities. Remote biometric identification systems
should therefore be classified as high-risk in view of the risks that they pose.
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The risk of biased results and
discrimination is especially important when it comes to age, ethnicity, race, sex, or disabilities. Therefore,
remote biometric identification systems should be considered high-risk due to these potential dangers. However,
AI systems used solely for biometric verification—like confirming a person's identity for accessing services, unlocking devices, or entering secure areas—are not classified as high-risk. Additionally,
AI systems that categorize individuals based on sensitive attributes protected under
Article 9(1) of
Regulation (EU) 2016/679, as well as emotion recognition systems that comply with this
regulation, should be classified as high-risk. On the other hand, biometric systems designed only for
cybersecurity and
personal data protection are not considered
high-risk AI systems. Furthermore,
AI systems used as
safety components in managing
critical infrastructure—such as digital infrastructure, road traffic, and the supply of water, gas, heating, and electricity—should also be classified as high-risk. This is because any failure in these systems could endanger lives and disrupt social and economic activities significantly.
effects. The risk of such biased results and discriminatory effects is
particularly relevant with regard to age, ethnicity, race, sex or disabilities. Remote biometric identification systems
should therefore be classified as high-risk in view of the risks that they pose. Such a classification excludes AI
systems intended to be used for biometric verification, including authentication, the sole purpose of which is to
confirm that a specific natural person is who that person claims to be and to confirm the identity of a natural person
for the sole purpose of having access to a service, unlocking a device or having secure access to premises. In addition,
AI systems intended to be used for biometric categorisation according to sensitive attributes or characteristics
protected under Article 9(1) of Regulation (EU) 2016/679 on the basis of biometric data, in so far as these are not
prohibited under this Regulation, and emotion recognition systems that are not prohibited under this Regulation,
should be classified as high-risk. Biometric systems which are intended to be used solely for the purpose of enabling
cybersecurity and personal data protection measures should not be considered to be high-risk AI systems.
(55)
As regards the management and operation of critical infrastructure, it is appropriate to classify as high-risk the AI
systems intended to be used as safety components in the management and operation of critical digital infrastructure
as listed in point (8) of the Annex to Directive (EU) 2022/2557, road traffic and the supply of water, gas, heating and
electricity, since their failure or malfunctioning may put at risk the life and health of persons at large scale and lead to
appreciable disruptions in the ordinary conduct of social and economic activities.
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The supply of water, gas, heating, and electricity is crucial because their failure can endanger people's lives and health on a large scale, disrupting everyday social and economic activities.
Safety components of
critical infrastructure, including digital systems, are designed to protect the physical integrity of this infrastructure and ensure the safety of people and property, but they are not essential for the system's basic operation. If these
safety components fail, they can pose risks to both the infrastructure and public safety. However, components meant only for
cybersecurity do not count as
safety components. Examples of
safety components include systems that monitor water pressure or fire alarm systems in cloud computing centers.
The use of
AI systems in education is vital for providing high-quality digital education and training. These systems help learners and teachers develop essential digital skills, such as
media literacy and
critical thinking, which are necessary for participating in the economy, society, and democratic processes. However,
AI systems that determine access to educational programs, evaluate learning outcomes, assess individual education levels, or monitor student behavior during tests should be considered high-risk. This is because they can significantly influence a person's educational and professional path.
the supply of water, gas, heating and
electricity, since their failure or malfunctioning may put at risk the life and health of persons at large scale and lead to
appreciable disruptions in the ordinary conduct of social and economic activities. Safety components of critical
infrastructure, including critical digital infrastructure, are systems used to directly protect the physical integrity of
critical infrastructure or the health and safety of persons and property but which are not necessary in order for the
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system to function. The failure or malfunctioning of such components might directly lead to risks to the physical
integrity of critical infrastructure and thus to risks to health and safety of persons and property. Components
intended to be used solely for cybersecurity purposes should not qualify as safety components. Examples of safety
components of such critical infrastructure may include systems for monitoring water pressure or fire alarm
controlling systems in cloud computing centres.
(56)
The deployment of AI systems in education is important to promote high-quality digital education and training and
to allow all learners and teachers to acquire and share the necessary digital skills and competences, including media
literacy, and critical thinking, to take an active part in the economy, society, and in democratic processes. However,
AI systems used in education or vocational training, in particular for determining access or admission, for assigning
persons to educational and vocational training institutions or programmes at all levels, for evaluating learning
outcomes of persons, for assessing the appropriate level of education for an individual and materially influencing the
level of education and training that individuals will receive or will be able to access or for monitoring and detecting
prohibited behaviour of students during tests should be classified as high-risk AI systems, since they may determine
the educational and professional course of a person’s life and therefore may
Show original text
AI systems that monitor students during tests or assess their behavior should be considered high-risk because they can significantly impact a person's education and career, potentially affecting their ability to earn a living. If these systems are not designed and used properly, they can invade privacy and violate rights to education and non-
discrimination, particularly affecting women, certain age groups, people with disabilities, and individuals from specific racial, ethnic, or sexual orientation backgrounds.
Similarly,
AI systems used in hiring, managing employees, and self-employment should also be classified as high-risk. These systems can influence job prospects, workers' rights, and livelihoods. It is important that employees and service
providers are meaningfully involved in work-related decisions, as these systems can reinforce existing
discrimination patterns against various groups. Additionally,
AI systems that monitor employee performance may infringe on their rights to
data protection and privacy.
that individuals will receive or will be able to access or for monitoring and detecting
prohibited behaviour of students during tests should be classified as high-risk AI systems, since they may determine
the educational and professional course of a person’s life and therefore may affect that person’s ability to secure
a livelihood. When improperly designed and used, such systems may be particularly intrusive and may violate the
right to education and training as well as the right not to be discriminated against and perpetuate historical patterns
of discrimination, for example against women, certain age groups, persons with disabilities, or persons of certain
racial or ethnic origins or sexual orientation.
(57)
AI systems used in employment, workers management and access to self-employment, in particular for the
recruitment and selection of persons, for making decisions affecting terms of the work-related relationship,
promotion and termination of work-related contractual relationships, for allocating tasks on the basis of individual
behaviour, personal traits or characteristics and for monitoring or evaluation of persons in work-related contractual
relationships, should also be classified as high-risk, since those systems may have an appreciable impact on future
career prospects, livelihoods of those persons and workers’ rights. Relevant work-related contractual relationships
should, in a meaningful manner, involve employees and persons providing services through platforms as referred to
in the Commission Work Programme 2021. Throughout the recruitment process and in the evaluation, promotion,
or retention of persons in work-related contractual relationships, such systems may perpetuate historical patterns of
discrimination, for example against women, certain age groups, persons with disabilities, or persons of certain racial
or ethnic origins or sexual orientation. AI systems used to monitor the performance and behaviour of such persons
may also undermine their fundamental rights to data protection and privacy.
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AI systems can negatively affect certain groups, including women, people of specific ages, individuals with disabilities, and those from particular racial, ethnic, or sexual orientation backgrounds. These systems may violate their rights to
data protection and privacy.
AI's role in accessing essential public and private services is also important. People who rely on public assistance, such as healthcare, social security, and housing support, are often in vulnerable situations. If
AI is used to decide whether these benefits should be granted or taken away, it can significantly impact their lives and violate their rights to social protection, non-
discrimination, and dignity. Therefore, these
AI systems should be considered high-risk.
However, this
regulation should not prevent the development of innovative and safe
AI solutions in public administration, as long as they do not pose high risks to individuals or legal entities. Additionally,
AI systems that assess credit scores or creditworthiness should also be classified as high-risk, as they affect access to financial resources and essential services like housing, electricity, and telecommunications.
example against women, certain age groups, persons with disabilities, or persons of certain racial
or ethnic origins or sexual orientation. AI systems used to monitor the performance and behaviour of such persons
may also undermine their fundamental rights to data protection and privacy.
(58)
Another area in which the use of AI systems deserves special consideration is the access to and enjoyment of certain
essential private and public services and benefits necessary for people to fully participate in society or to improve
one’s standard of living. In particular, natural persons applying for or receiving essential public assistance benefits
and services from public authorities namely healthcare services, social security benefits, social services providing
protection in cases such as maternity, illness, industrial accidents, dependency or old age and loss of employment
and social and housing assistance, are typically dependent on those benefits and services and in a vulnerable position
in relation to the responsible authorities. If AI systems are used for determining whether such benefits and services
should be granted, denied, reduced, revoked or reclaimed by authorities, including whether beneficiaries are
legitimately entitled to such benefits or services, those systems may have a significant impact on persons’ livelihood
and may infringe their fundamental rights, such as the right to social protection, non-discrimination, human dignity
or an effective remedy and should therefore be classified as high-risk. Nonetheless, this Regulation should not
hamper the development and use of innovative approaches in the public administration, which would stand to
benefit from a wider use of compliant and safe AI systems, provided that those systems do not entail a high risk to
legal and natural persons. In addition, AI systems used to evaluate the credit score or creditworthiness of natural
persons should be classified as high-risk AI systems, since they determine those persons’ access to financial resources
or essential services such as housing, electricity, and telecommunication services.
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AI systems that assess the credit scores or creditworthiness of individuals should be labeled as high-risk because they influence access to financial resources and essential services like housing, electricity, and telecommunications. These systems can lead to
discrimination against individuals or groups based on factors such as race, ethnicity, gender, disabilities, age, or sexual orientation, and may also create new forms of
discrimination. However,
AI systems used under
Union law to detect fraud in financial services and to calculate capital requirements for banks and insurance companies are not considered high-risk under this
regulation. Additionally,
AI systems used for
risk assessment and pricing in health and life insurance can significantly affect people's lives and, if not properly designed, may violate their
fundamental rights, leading to financial exclusion and
discrimination. Lastly,
AI systems that evaluate and prioritize emergency calls or dispatch emergency services, including police, firefighters, and medical aid, should also be classified as high-risk due to their critical role in life-and-death situations.
AI systems used to evaluate the credit score or creditworthiness of natural
persons should be classified as high-risk AI systems, since they determine those persons’ access to financial resources
or essential services such as housing, electricity, and telecommunication services. AI systems used for those purposes
may lead to discrimination between persons or groups and may perpetuate historical patterns of discrimination,
such as that based on racial or ethnic origins, gender, disabilities, age or sexual orientation, or may create new forms
of discriminatory impacts. However, AI systems provided for by Union law for the purpose of detecting fraud in the
offering of financial services and for prudential purposes to calculate credit institutions’ and insurance undertakings’
capital requirements should not be considered to be high-risk under this Regulation. Moreover, AI systems intended
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to be used for risk assessment and pricing in relation to natural persons for health and life insurance can also have
a significant impact on persons’ livelihood and if not duly designed, developed and used, can infringe their
fundamental rights and can lead to serious consequences for people’s life and health, including financial exclusion
and discrimination. Finally, AI systems used to evaluate and classify emergency calls by natural persons or to
dispatch or establish priority in the dispatching of emergency first response services, including by police, firefighters
and medical aid, as well as of emergency healthcare patient triage systems, should also be classified as high-risk since
they make decisions in very critical situations for the life and health of persons and their property.
Show original text
Services provided by police, firefighters, and medical aid, as well as emergency healthcare patient triage systems, should be considered high-risk. This is because they make critical decisions that affect people's lives, health, and property. Actions taken by
law enforcement using certain
AI systems can create a power imbalance and may result in surveillance, arrests, or loss of personal freedom, which can negatively impact
fundamental rights protected by the
Charter. If an
AI system is not trained with
high-quality data, lacks proper performance,
accuracy, or
robustness, or is not adequately designed and tested before use, it may unfairly target individuals in a discriminatory way. Additionally, important rights such as the right to an
effective remedy, a
fair trial, the right to defend oneself, and the
presumption of innocence could be compromised if these
AI systems lack
transparency, explainability, and proper documentation. Therefore, it is appropriate to classify certain
AI systems used in
law enforcement as high-risk, as their
accuracy, reliability, and
transparency are crucial to prevent negative consequences, maintain public trust, and ensure accountability and effective remedies.
services, including by police, firefighters
and medical aid, as well as of emergency healthcare patient triage systems, should also be classified as high-risk since
they make decisions in very critical situations for the life and health of persons and their property.
(59)
Given their role and responsibility, actions by law enforcement authorities involving certain uses of AI systems are
characterised by a significant degree of power imbalance and may lead to surveillance, arrest or deprivation of
a natural person’s liberty as well as other adverse impacts on fundamental rights guaranteed in the Charter. In
particular, if the AI system is not trained with high-quality data, does not meet adequate requirements in terms of its
performance, its accuracy or robustness, or is not properly designed and tested before being put on the market or
otherwise put into service, it may single out people in a discriminatory or otherwise incorrect or unjust manner.
Furthermore, the exercise of important procedural fundamental rights, such as the right to an effective remedy and
to a fair trial as well as the right of defence and the presumption of innocence, could be hampered, in particular,
where such AI systems are not sufficiently transparent, explainable and documented. It is therefore appropriate to
classify as high-risk, insofar as their use is permitted under relevant Union and national law, a number of AI systems
intended to be used in the law enforcement context where accuracy, reliability and transparency is particularly
important to avoid adverse impacts, retain public trust and ensure accountability and effective redress.
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Under relevant
Union and national laws, certain
AI systems are allowed for use in
law enforcement, where
accuracy, reliability, and
transparency are crucial to maintain public trust and ensure accountability.
High-risk AI systems include those used by
law enforcement authorities or
Union institutions to assess the risk of individuals becoming victims of crimes, such as
polygraphs and similar tools. These systems may also evaluate the reliability of evidence during criminal investigations or prosecutions. However, they should not solely rely on profiling individuals based on personality traits or past criminal behavior.
AI systems used for administrative tasks by tax and customs authorities or financial intelligence units under anti-money laundering laws are not classified as high-risk for
law enforcement purposes. The use of
AI by
law enforcement should not create inequality or exclusion. It is important to consider how
AI tools affect the defense rights of suspects, especially regarding their ability to understand and challenge the results of these systems in court.
permitted under relevant Union and national law, a number of AI systems
intended to be used in the law enforcement context where accuracy, reliability and transparency is particularly
important to avoid adverse impacts, retain public trust and ensure accountability and effective redress. In view of the
nature of the activities and the risks relating thereto, those high-risk AI systems should include in particular AI
systems intended to be used by or on behalf of law enforcement authorities or by Union institutions, bodies, offices,
or agencies in support of law enforcement authorities for assessing the risk of a natural person to become a victim of
criminal offences, as polygraphs and similar tools, for the evaluation of the reliability of evidence in in the course of
investigation or prosecution of criminal offences, and, insofar as not prohibited under this Regulation, for assessing
the risk of a natural person offending or reoffending not solely on the basis of the profiling of natural persons or the
assessment of personality traits and characteristics or the past criminal behaviour of natural persons or groups, for
profiling in the course of detection, investigation or prosecution of criminal offences. AI systems specifically
intended to be used for administrative proceedings by tax and customs authorities as well as by financial intelligence
units carrying out administrative tasks analysing information pursuant to Union anti-money laundering law should
not be classified as high-risk AI systems used by law enforcement authorities for the purpose of prevention,
detection, investigation and prosecution of criminal offences. The use of AI tools by law enforcement and other
relevant authorities should not become a factor of inequality, or exclusion. The impact of the use of AI tools on the
defence rights of suspects should not be ignored, in particular the difficulty in obtaining meaningful information on
the functioning of those systems and the resulting difficulty in challenging their results in court, in particular by
natural persons under investigation.
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The use of
AI tools in the defense rights of suspects is important and should not be overlooked. There are challenges in understanding how these systems work, which makes it hard for individuals under investigation to contest their results in court.
AI systems used in
migration,
asylum, and border control impact vulnerable individuals who rely on the decisions made by
public authorities. Therefore, it is crucial that these
AI systems are accurate, non-discriminatory, and transparent to protect the
fundamental rights of these individuals, including their rights to free movement, non-
discrimination, privacy, international protection, and fair administration.
AI systems used by
public authorities or EU institutions in
migration,
asylum, and border control should be classified as high-risk. This includes tools like
polygraphs that assess risks for individuals entering a
Member State or applying for visas or
asylum. These systems should also help authorities evaluate applications for
asylum, visas, and residence permits, and assist in identifying individuals in
migration contexts, excluding travel document verification.
AI systems in this area must comply with the procedural requirements set by
Regulation (EC) No 810/2009 of the
European Parliament.
AI tools on the
defence rights of suspects should not be ignored, in particular the difficulty in obtaining meaningful information on
the functioning of those systems and the resulting difficulty in challenging their results in court, in particular by
natural persons under investigation.
(60)
AI systems used in migration, asylum and border control management affect persons who are often in particularly
vulnerable position and who are dependent on the outcome of the actions of the competent public authorities. The
accuracy, non-discriminatory nature and transparency of the AI systems used in those contexts are therefore
particularly important to guarantee respect for the fundamental rights of the affected persons, in particular their
rights to free movement, non-discrimination, protection of private life and personal data, international protection
and good administration. It is therefore appropriate to classify as high-risk, insofar as their use is permitted under
relevant Union and national law, AI systems intended to be used by or on behalf of competent public authorities or
by Union institutions, bodies, offices or agencies charged with tasks in the fields of migration, asylum and border
control management as polygraphs and similar tools, for assessing certain risks posed by natural persons entering
the territory of a Member State or applying for visa or asylum, for assisting competent public authorities for the
examination, including related assessment of the reliability of evidence, of applications for asylum, visa and residence
permits and associated complaints with regard to the objective to establish the eligibility of the natural persons
applying for a status, for the purpose of detecting, recognising or identifying natural persons in the context of
migration, asylum and border control management, with the exception of verification of travel documents. AI
systems in the area of migration, asylum and border control management covered by this Regulation should comply
with the relevant procedural requirements set by the Regulation (EC) No 810/2009 of the European Parliament and
OJ L, 12.7.
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The
regulation on
migration,
asylum, and border control must follow the procedural rules set by
Regulation (EC) No 810/2009 and
Directive 2013/32/EU, along with other relevant EU laws.
AI systems used in these areas cannot be employed by
Member States or EU institutions to bypass their international
obligations under the UN Convention on Refugees from July 28, 1951, and its 1967 Protocol. They must not violate the principle of non-refoulement or restrict safe and legal access to the EU, including the right to seek international protection. Additionally, certain
AI systems used in justice and democratic processes are classified as high-risk due to their significant impact on democracy, the rule of law, individual freedoms, and the right to a
fair trial. This includes
AI systems used by judicial authorities to assist in legal research and decision-making, as well as those used in alternative dispute resolution that have legal consequences for the parties involved.
the area of migration, asylum and border control management covered by this Regulation should comply
with the relevant procedural requirements set by the Regulation (EC) No 810/2009 of the European Parliament and
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of the Council (32), the Directive 2013/32/EU of the European Parliament and of the Council (33), and other relevant
Union law. The use of AI systems in migration, asylum and border control management should, in no circumstances,
be used by Member States or Union institutions, bodies, offices or agencies as a means to circumvent their
international obligations under the UN Convention relating to the Status of Refugees done at Geneva on 28 July
1951 as amended by the Protocol of 31 January 1967. Nor should they be used to in any way infringe on the
principle of non-refoulement, or to deny safe and effective legal avenues into the territory of the Union, including
the right to international protection.
(61)
Certain AI systems intended for the administration of justice and democratic processes should be classified as
high-risk, considering their potentially significant impact on democracy, the rule of law, individual freedoms as well
as the right to an effective remedy and to a fair trial. In particular, to address the risks of potential biases, errors and
opacity, it is appropriate to qualify as high-risk AI systems intended to be used by a judicial authority or on its behalf
to assist judicial authorities in researching and interpreting facts and the law and in applying the law to a concrete set
of facts. AI systems intended to be used by alternative dispute resolution bodies for those purposes should also be
considered to be high-risk when the outcomes of the alternative dispute resolution proceedings produce legal effects
for the parties.
Show original text
AI systems used in alternative dispute resolution (ADR) should be considered high-risk if their outcomes have legal consequences for the parties involved. While
AI can assist judges in making decisions, it should not replace human judgment; final decisions must always be made by people. However,
AI systems used for administrative tasks that do not impact individual cases, like anonymizing judicial documents or facilitating communication among staff, are not classified as high-risk.
Additionally,
AI systems that aim to influence election outcomes or voter behavior should also be classified as high-risk, except for those that are not directly seen by voters, such as tools for organizing political campaigns.
It's important to note that being classified as high-risk under this
regulation does not mean that the use of the
AI system is legal under other EU or national laws, including those related to
personal data protection or tools that assess people's emotional states.
law to a concrete set
of facts. AI systems intended to be used by alternative dispute resolution bodies for those purposes should also be
considered to be high-risk when the outcomes of the alternative dispute resolution proceedings produce legal effects
for the parties. The use of AI tools can support the decision-making power of judges or judicial independence, but
should not replace it: the final decision-making must remain a human-driven activity. The classification of AI
systems as high-risk should not, however, extend to AI systems intended for purely ancillary administrative activities
that do not affect the actual administration of justice in individual cases, such as anonymisation or
pseudonymisation of judicial decisions, documents or data, communication between personnel, administrative tasks.
(62)
Without prejudice to the rules provided for in Regulation (EU) 2024/900 of the European Parliament and of the
Council (34), and in order to address the risks of undue external interference with the right to vote enshrined in
Article 39 of the Charter, and of adverse effects on democracy and the rule of law, AI systems intended to be used to
influence the outcome of an election or referendum or the voting behaviour of natural persons in the exercise of
their vote in elections or referenda should be classified as high-risk AI systems with the exception of AI systems
whose output natural persons are not directly exposed to, such as tools used to organise, optimise and structure
political campaigns from an administrative and logistical point of view.
(63)
The fact that an AI system is classified as a high-risk AI system under this Regulation should not be interpreted as
indicating that the use of the system is lawful under other acts of Union law or under national law compatible with
Union law, such as on the protection of personal data, on the use of polygraphs and similar tools or other systems to
detect the emotional state of natural persons.
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The system is legal under various
Union laws and national laws that align with
Union law, such as those protecting
personal data and regulating the use of
polygraphs and similar tools to assess people's emotions. Any use of these tools must comply with the
Charter and relevant
Union and national laws. This
Regulation does not provide a legal basis for processing
personal data, including sensitive
data, unless explicitly stated otherwise in the
Regulation.
To reduce risks from
high-risk AI systems that are marketed or used, certain mandatory requirements must be met. These requirements will consider the intended use and context of the
AI system, as well as the
risk management system established by the
provider. The measures taken by
providers to meet these requirements should reflect the current best practices in
AI and be effective in achieving the
Regulation's goals. According to the
New Legislative Framework, as explained in the
Commission's 'Blue Guide' on EU product rules from 2022, multiple
Union laws may apply to a single product. A product can only be made available or used if it complies with all relevant
Union laws. The risks associated with
AI systems addressed by this
Regulation differ from those covered by existing
Union laws, meaning this
Regulation will add to the current legal framework.
system is lawful under other acts of Union law or under national law compatible with
Union law, such as on the protection of personal data, on the use of polygraphs and similar tools or other systems to
detect the emotional state of natural persons. Any such use should continue to occur solely in accordance with the
applicable requirements resulting from the Charter and from the applicable acts of secondary Union law and
national law. This Regulation should not be understood as providing for the legal ground for processing of personal
data, including special categories of personal data, where relevant, unless it is specifically otherwise provided for in
this Regulation.
(64)
To mitigate the risks from high-risk AI systems placed on the market or put into service and to ensure a high level of
trustworthiness, certain mandatory requirements should apply to high-risk AI systems, taking into account the
intended purpose and the context of use of the AI system and according to the risk-management system to be
established by the provider. The measures adopted by the providers to comply with the mandatory requirements of
this Regulation should take into account the generally acknowledged state of the art on AI, be proportionate and
effective to meet the objectives of this Regulation. Based on the New Legislative Framework, as clarified in
Commission notice ‘The “Blue Guide” on the implementation of EU product rules 2022’, the general rule is that
more than one legal act of Union harmonisation legislation may be applicable to one product, since the making
available or putting into service can take place only when the product complies with all applicable Union
harmonisation legislation. The hazards of AI systems covered by the requirements of this Regulation concern
different aspects than the existing Union harmonisation legislation and therefore the requirements of this Regulation
would complement the existing body of the Union harmonisation legislation.
Show original text
Union
harmonisation legislation. The hazards of AI systems covered by the requirements of this Regulation concern
different aspects than the existing Union harmonisation legislation and therefore the requirements of this Regulation
would complement the existing body of the Union harmonisation legislation. For example, machinery or medical
devices products incorporating an AI system might present risks not addressed by the essential health and safety
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(32)
Regulation (EC) No 810/2009 of the European Parliament and of the Council of 13 July 2009 establishing a Community Code on
Visas (Visa Code) (OJ L 243, 15.9.2009, p. 1).
(33)
Directive 2013/32/EU of the European Parliament and of the Council of 26 June 2013 on common procedures for granting and
withdrawing international protection (OJ L 180, 29.6.2013, p. 60).
(34)
Regulation (EU) 2024/900 of the European parliament and of the Council of 13 March 2024 on the transparency and targeting of
political advertising (OJ L, 2024/900, 20.3.2024, ELI: http://data.europa.eu/eli/reg/2024/900/oj).
requirements set out in the relevant Union harmonised legislation, as that sectoral law does not deal with risks
specific to AI systems. This calls for a simultaneous and complementary application of the various legislative acts.
Show original text
The requirements outlined in the relevant
European Union laws do not specifically address the risks associated with
AI systems. Therefore, it is necessary to apply various laws together. To maintain consistency and reduce unnecessary administrative burdens and costs,
providers of products that include
high-risk AI systems should have the flexibility to decide how to comply with all applicable laws. This flexibility might allow
providers to combine some of the testing and reporting processes required by this
Regulation with existing documentation and procedures from other EU laws. However, this does not lessen their obligation to meet all requirements.
The
risk management system for
high-risk AI systems should be a continuous process that is planned and executed throughout the system's entire lifecycle. This process aims to identify and reduce risks related to health, safety, and
fundamental rights. The
risk management system should be regularly reviewed and updated to ensure it remains effective, and any significant decisions and actions taken under this
Regulation should be documented and justified.
/reg/2024/900/oj).
requirements set out in the relevant Union harmonised legislation, as that sectoral law does not deal with risks
specific to AI systems. This calls for a simultaneous and complementary application of the various legislative acts. To
ensure consistency and to avoid an unnecessary administrative burden and unnecessary costs, providers of a product
that contains one or more high-risk AI system, to which the requirements of this Regulation and of the Union
harmonisation legislation based on the New Legislative Framework and listed in an annex to this Regulation apply,
should have flexibility with regard to operational decisions on how to ensure compliance of a product that contains
one or more AI systems with all the applicable requirements of that Union harmonised legislation in an optimal
manner. That flexibility could mean, for example a decision by the provider to integrate a part of the necessary
testing and reporting processes, information and documentation required under this Regulation into already existing
documentation and procedures required under existing Union harmonisation legislation based on the New
Legislative Framework and listed in an annex to this Regulation. This should not, in any way, undermine the
obligation of the provider to comply with all the applicable requirements.
(65)
The risk-management system should consist of a continuous, iterative process that is planned and run throughout
the entire lifecycle of a high-risk AI system. That process should be aimed at identifying and mitigating the relevant
risks of AI systems on health, safety and fundamental rights. The risk-management system should be regularly
reviewed and updated to ensure its continuing effectiveness, as well as justification and documentation of any
significant decisions and actions taken subject to this Regulation.
Show original text
AI systems can pose risks to health, safety, and
fundamental rights.
Providers must regularly review and update their risk-management systems to ensure they remain effective. They should document significant decisions and actions taken under this
regulation. This process helps
providers identify risks and implement measures to reduce known and foreseeable risks related to the
AI system's intended use and potential misuse, including risks from the
AI's interaction with its environment.
Providers should choose the best risk-management measures based on the latest advancements in
AI technology. When selecting these measures, they should document their decisions and involve experts and
stakeholders when relevant.
Providers must also consider potential misuses of
high-risk AI systems that may not be directly related to their intended purpose but could arise from predictable human behavior. Any known risks associated with the intended use or foreseeable misuse of
high-risk AI systems should be included in the user instructions provided by the
provider. This ensures that
users are aware of these risks when operating the
AI system. Identifying and implementing measures to mitigate foreseeable misuse should not require additional training for the
AI system. However,
providers are encouraged to consider offering extra training to address reasonable foreseeable misuses when necessary.
risks of AI systems on health, safety and fundamental rights. The risk-management system should be regularly
reviewed and updated to ensure its continuing effectiveness, as well as justification and documentation of any
significant decisions and actions taken subject to this Regulation. This process should ensure that the provider
identifies risks or adverse impacts and implements mitigation measures for the known and reasonably foreseeable
risks of AI systems to the health, safety and fundamental rights in light of their intended purpose and reasonably
foreseeable misuse, including the possible risks arising from the interaction between the AI system and the
environment within which it operates. The risk-management system should adopt the most appropriate
risk-management measures in light of the state of the art in AI. When identifying the most appropriate
risk-management measures, the provider should document and explain the choices made and, when relevant,
involve experts and external stakeholders. In identifying the reasonably foreseeable misuse of high-risk AI systems,
the provider should cover uses of AI systems which, while not directly covered by the intended purpose and
provided for in the instruction for use may nevertheless be reasonably expected to result from readily predictable
human behaviour in the context of the specific characteristics and use of a particular AI system. Any known or
foreseeable circumstances related to the use of the high-risk AI system in accordance with its intended purpose or
under conditions of reasonably foreseeable misuse, which may lead to risks to the health and safety or fundamental
rights should be included in the instructions for use that are provided by the provider. This is to ensure that the
deployer is aware and takes them into account when using the high-risk AI system. Identifying and implementing
risk mitigation measures for foreseeable misuse under this Regulation should not require specific additional training
for the high-risk AI system by the provider to address foreseeable misuse. The providers however are encouraged to
consider such additional training measures to mitigate reasonable foreseeable misuses as necessary and appropriate.
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Providers of
high-risk AI systems do not need to provide specific additional training to prevent foreseeable misuse under this
Regulation. However, they are encouraged to consider extra training measures to reduce potential misuses when necessary.
High-risk AI systems must meet requirements related to risk management,
data quality and relevance,
technical documentation, record-keeping,
transparency,
human oversight, and
cybersecurity. These requirements are essential to protect health, safety, and
fundamental rights, and they do not unjustly restrict trade since no less trade-restrictive options are available.
Access to
high-quality data is crucial for the effective functioning of
AI systems, especially those that rely on
model training. This ensures that
high-risk AI systems operate safely and do not lead to
discrimination, as prohibited by
Union law. To create high-quality training, validation, and
testing data sets, proper
data governance and management practices must be implemented. These
data sets should be relevant, representative, and as error-free and complete as possible for their intended use. Additionally, to comply with
Union data protection laws, such as
Regulation (EU) 2016/679,
data governance practices should ensure
transparency about the original purpose of
data collection, especially for
personal data.
for foreseeable misuse under this Regulation should not require specific additional training
for the high-risk AI system by the provider to address foreseeable misuse. The providers however are encouraged to
consider such additional training measures to mitigate reasonable foreseeable misuses as necessary and appropriate.
(66)
Requirements should apply to high-risk AI systems as regards risk management, the quality and relevance of data
sets used, technical documentation and record-keeping, transparency and the provision of information to deployers,
human oversight, and robustness, accuracy and cybersecurity. Those requirements are necessary to effectively
mitigate the risks for health, safety and fundamental rights. As no other less trade restrictive measures are reasonably
available those requirements are not unjustified restrictions to trade.
(67)
High-quality data and access to high-quality data plays a vital role in providing structure and in ensuring the
performance of many AI systems, especially when techniques involving the training of models are used, with a view
to ensure that the high-risk AI system performs as intended and safely and it does not become a source of
discrimination prohibited by Union law. High-quality data sets for training, validation and testing require the
implementation of appropriate data governance and management practices. Data sets for training, validation and
testing, including the labels, should be relevant, sufficiently representative, and to the best extent possible free of
errors and complete in view of the intended purpose of the system. In order to facilitate compliance with Union data
protection law, such as Regulation (EU) 2016/679, data governance and management practices should include, in
the case of personal data, transparency about the original purpose of the data collection.
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To comply with
Union data protection laws, like
Regulation (EU) 2016/679,
data management practices must ensure
transparency about why
personal data is collected.
Data sets should have the right statistical properties, especially regarding the individuals or groups for whom
high-risk AI systems are designed. It's crucial to address potential biases in these
data sets, as they can negatively impact people's
health and safety, violate
fundamental rights, or lead to
discrimination, particularly when the
data influences future operations (
feedback loops). Biases may arise from the
data itself, especially if historical
data is used, or from how the systems are applied in real-world situations.
AI system results can be affected by these biases, which may worsen and perpetuate existing
discrimination, especially against
vulnerable groups like racial or ethnic minorities. While
data sets should be as complete and accurate as possible, this should not hinder the use of privacy-preserving methods during
AI development and testing. Additionally,
data sets should consider the specific geographical, contextual, behavioral, or functional aspects relevant to the
AI system's intended use.
order to facilitate compliance with Union data
protection law, such as Regulation (EU) 2016/679, data governance and management practices should include, in
the case of personal data, transparency about the original purpose of the data collection. The data sets should also
have the appropriate statistical properties, including as regards the persons or groups of persons in relation to whom
the high-risk AI system is intended to be used, with specific attention to the mitigation of possible biases in the data
sets, that are likely to affect the health and safety of persons, have a negative impact on fundamental rights or lead to
discrimination prohibited under Union law, especially where data outputs influence inputs for future operations
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(feedback loops). Biases can for example be inherent in underlying data sets, especially when historical data is being
used, or generated when the systems are implemented in real world settings. Results provided by AI systems could be
influenced by such inherent biases that are inclined to gradually increase and thereby perpetuate and amplify existing
discrimination, in particular for persons belonging to certain vulnerable groups, including racial or ethnic groups.
The requirement for the data sets to be to the best extent possible complete and free of errors should not affect the
use of privacy-preserving techniques in the context of the development and testing of AI systems. In particular, data
sets should take into account, to the extent required by their intended purpose, the features, characteristics or
elements that are particular to the specific geographical, contextual, behavioural or functional setting which the AI
system is intended to be used.
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Data sets used for
AI systems should consider the specific geographical, contextual, behavioral, or functional aspects relevant to their intended use. To meet
data governance requirements, organizations can use third-party services that provide certified compliance, ensuring the integrity of
data sets and proper practices for
data training, validation, and testing in line with regulations.
For
high-risk AI systems,
providers,
notified bodies, and other relevant entities, such as
European Digital Innovation Hubs and researchers, should have access to
high-quality data sets related to their activities. The
European Commission's establishment of common
data spaces and promotion of
data sharing between businesses and government will help ensure trustworthy and fair access to
quality data for training, validating, and testing
AI systems. For instance, the
European health data space will allow equitable access to health
data for training
AI algorithms while maintaining privacy, security,
transparency, and proper governance. Relevant authorities can also assist in providing
high-quality data for these purposes.
Throughout the entire lifecycle of an
AI system, the right to privacy and protection of
personal data must be upheld. This includes adhering to principles of
data minimization and ensuring
data protection by design and by default, as outlined in EU
data protection laws when handling
personal data.
, data
sets should take into account, to the extent required by their intended purpose, the features, characteristics or
elements that are particular to the specific geographical, contextual, behavioural or functional setting which the AI
system is intended to be used. The requirements related to data governance can be complied with by having recourse
to third parties that offer certified compliance services including verification of data governance, data set integrity,
and data training, validation and testing practices, as far as compliance with the data requirements of this Regulation
are ensured.
(68)
For the development and assessment of high-risk AI systems, certain actors, such as providers, notified bodies and
other relevant entities, such as European Digital Innovation Hubs, testing experimentation facilities and researchers,
should be able to access and use high-quality data sets within the fields of activities of those actors which are related
to this Regulation. European common data spaces established by the Commission and the facilitation of data sharing
between businesses and with government in the public interest will be instrumental to provide trustful, accountable
and non-discriminatory access to high-quality data for the training, validation and testing of AI systems. For
example, in health, the European health data space will facilitate non-discriminatory access to health data and the
training of AI algorithms on those data sets, in a privacy-preserving, secure, timely, transparent and trustworthy
manner, and with an appropriate institutional governance. Relevant competent authorities, including sectoral ones,
providing or supporting the access to data may also support the provision of high-quality data for the training,
validation and testing of AI systems.
(69)
The right to privacy and to protection of personal data must be guaranteed throughout the entire lifecycle of the AI
system. In this regard, the principles of data minimisation and data protection by design and by default, as set out in
Union data protection law, are applicable when personal data are processed.
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The entire lifecycle of an
AI system must ensure
data protection. This means following the principles of
data minimization and
data protection by design and by default, as outlined in EU
data protection laws when handling
personal data.
Providers can comply with these principles by using methods like anonymization and encryption, as well as technologies that allow algorithms to access
data without transferring or copying the actual
data itself, while still adhering to
data governance requirements in this
Regulation.
To prevent
discrimination caused by bias in
AI systems,
providers may need to process special categories of
personal data, but only when absolutely necessary for detecting and correcting bias in
high-risk AI systems. This must be done with appropriate
safeguards for individual rights and in accordance with the conditions set out in this
Regulation and other relevant EU regulations.
It is crucial to have clear information about how
high-risk AI systems are developed and how they operate over time. This
transparency is necessary for tracking these systems, ensuring they meet regulatory requirements, and monitoring their performance after they are on the market.
must be guaranteed throughout the entire lifecycle of the AI
system. In this regard, the principles of data minimisation and data protection by design and by default, as set out in
Union data protection law, are applicable when personal data are processed. Measures taken by providers to ensure
compliance with those principles may include not only anonymisation and encryption, but also the use of
technology that permits algorithms to be brought to the data and allows training of AI systems without the
transmission between parties or copying of the raw or structured data themselves, without prejudice to the
requirements on data governance provided for in this Regulation.
(70)
In order to protect the right of others from the discrimination that might result from the bias in AI systems, the
providers should, exceptionally, to the extent that it is strictly necessary for the purpose of ensuring bias detection
and correction in relation to the high-risk AI systems, subject to appropriate safeguards for the fundamental rights
and freedoms of natural persons and following the application of all applicable conditions laid down under this
Regulation in addition to the conditions laid down in Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive
(EU) 2016/680, be able to process also special categories of personal data, as a matter of substantial public interest
within the meaning of Article 9(2), point (g) of Regulation (EU) 2016/679 and Article 10(2), point (g) of Regulation
(EU) 2018/1725.
(71)
Having comprehensible information on how high-risk AI systems have been developed and how they perform
throughout their lifetime is essential to enable traceability of those systems, verify compliance with the requirements
under this Regulation, as well as monitoring of their operations and post market monitoring.
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It is important to understand how
high-risk AI systems are developed and how they operate over time. This understanding helps ensure that these systems can be traced, comply with regulations, and are monitored after they are on the market. To achieve this, records and
technical documentation must be maintained. This documentation should include essential information to assess whether the
AI system meets the required standards and to support ongoing monitoring. Key details should cover the system's general characteristics, capabilities, limitations, algorithms,
data, and the processes used for training, testing, and validation. It should also include information about the
risk management system, presented clearly and comprehensively. The
technical documentation must be kept current throughout the
AI system's lifespan. Additionally,
high-risk AI systems should be designed to automatically log events during their operation.
To address concerns about the complexity and lack of
transparency in some
AI systems,
high-risk AI systems must provide clear information before they are sold or used. They should be designed so that
users can understand how they work, assess their functionality, and recognize their strengths and weaknesses.
Users should receive clear instructions that outline the system's characteristics, capabilities, and performance limitations.
on how high-risk AI systems have been developed and how they perform
throughout their lifetime is essential to enable traceability of those systems, verify compliance with the requirements
under this Regulation, as well as monitoring of their operations and post market monitoring. This requires keeping
records and the availability of technical documentation, containing information which is necessary to assess the
compliance of the AI system with the relevant requirements and facilitate post market monitoring. Such information
should include the general characteristics, capabilities and limitations of the system, algorithms, data, training,
testing and validation processes used as well as documentation on the relevant risk-management system and drawn
in a clear and comprehensive form. The technical documentation should be kept up to date, appropriately
throughout the lifetime of the AI system. Furthermore, high-risk AI systems should technically allow for the
automatic recording of events, by means of logs, over the duration of the lifetime of the system.
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(72)
To address concerns related to opacity and complexity of certain AI systems and help deployers to fulfil their
obligations under this Regulation, transparency should be required for high-risk AI systems before they are placed
on the market or put it into service. High-risk AI systems should be designed in a manner to enable deployers to
understand how the AI system works, evaluate its functionality, and comprehend its strengths and limitations.
High-risk AI systems should be accompanied by appropriate information in the form of instructions of use. Such
information should include the characteristics, capabilities and limitations of performance of the AI system.
Show original text
High-risk AI systems must come with clear instructions that explain how to use them, their features, capabilities, and limitations. These instructions should address known and expected situations that could affect the
AI system's behavior and performance, including actions by the user that might introduce risks to health, safety, and
fundamental rights. They should also outline any changes that have been evaluated for compliance by the
provider and detail relevant
human oversight measures to help
users interpret the
AI system's outputs.
Transparency in these instructions will help
users make informed decisions and choose the right system based on their
obligations.
Users should be educated about the intended and prohibited uses of the
AI system to ensure proper usage. To improve clarity, the instructions should include examples of limitations and appropriate uses.
Providers must ensure that all documentation, including usage instructions, is meaningful, comprehensive, accessible, and easy to understand, considering the knowledge level of the intended
users. Instructions should be available in a language that is easily understood by the target
users, as determined by the relevant
Member State.
works, evaluate its functionality, and comprehend its strengths and limitations.
High-risk AI systems should be accompanied by appropriate information in the form of instructions of use. Such
information should include the characteristics, capabilities and limitations of performance of the AI system. Those
would cover information on possible known and foreseeable circumstances related to the use of the high-risk AI
system, including deployer action that may influence system behaviour and performance, under which the AI system
can lead to risks to health, safety, and fundamental rights, on the changes that have been pre-determined and
assessed for conformity by the provider and on the relevant human oversight measures, including the measures to
facilitate the interpretation of the outputs of the AI system by the deployers. Transparency, including the
accompanying instructions for use, should assist deployers in the use of the system and support informed decision
making by them. Deployers should, inter alia, be in a better position to make the correct choice of the system that
they intend to use in light of the obligations applicable to them, be educated about the intended and precluded uses,
and use the AI system correctly and as appropriate. In order to enhance legibility and accessibility of the information
included in the instructions of use, where appropriate, illustrative examples, for instance on the limitations and on
the intended and precluded uses of the AI system, should be included. Providers should ensure that all
documentation, including the instructions for use, contains meaningful, comprehensive, accessible and
understandable information, taking into account the needs and foreseeable knowledge of the target deployers.
Instructions for use should be made available in a language which can be easily understood by target deployers, as
determined by the Member State concerned.
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Instructions for using
high-risk AI systems should be clear and easy to understand for the intended
users, as determined by the relevant
Member State. These systems must be designed so that people can monitor their operation, ensure they are used correctly, and manage their effects throughout their lifecycle. Before these systems are sold or put into use, the
provider must identify suitable
human oversight measures. These measures should ensure that the system has built-in limits that cannot be overridden by the system itself and that it responds to human operators. The individuals responsible for oversight must have the necessary skills, training, and authority. Additionally,
high-risk AI systems should include features that help these individuals make informed decisions about when and how to intervene to prevent negative outcomes or to stop the system if it malfunctions. For
biometric identification systems, which can have serious consequences if they make mistakes, there should be stricter oversight. No actions or decisions based on the system's identification should be made without verification from at least two people. These individuals can come from different organizations and may include the system's
operator. This verification process should not create unnecessary delays, and it can be sufficient for the system to automatically log these verifications.
understandable information, taking into account the needs and foreseeable knowledge of the target deployers.
Instructions for use should be made available in a language which can be easily understood by target deployers, as
determined by the Member State concerned.
(73)
High-risk AI systems should be designed and developed in such a way that natural persons can oversee their
functioning, ensure that they are used as intended and that their impacts are addressed over the system’s lifecycle. To
that end, appropriate human oversight measures should be identified by the provider of the system before its placing
on the market or putting into service. In particular, where appropriate, such measures should guarantee that the
system is subject to in-built operational constraints that cannot be overridden by the system itself and is responsive
to the human operator, and that the natural persons to whom human oversight has been assigned have the necessary
competence, training and authority to carry out that role. It is also essential, as appropriate, to ensure that high-risk
AI systems include mechanisms to guide and inform a natural person to whom human oversight has been assigned
to make informed decisions if, when and how to intervene in order to avoid negative consequences or risks, or stop
the system if it does not perform as intended. Considering the significant consequences for persons in the case of an
incorrect match by certain biometric identification systems, it is appropriate to provide for an enhanced human
oversight requirement for those systems so that no action or decision may be taken by the deployer on the basis of
the identification resulting from the system unless this has been separately verified and confirmed by at least two
natural persons. Those persons could be from one or more entities and include the person operating or using the
system. This requirement should not pose unnecessary burden or delays and it could be sufficient that the separate
verifications by the different persons are automatically recorded in the logs generated by the system.
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One or more entities, including the person using the system, must be involved. This requirement should not create unnecessary delays, and it may be enough for the system to automatically log separate verifications by different
users. In areas like
law enforcement,
migration, border control, and
asylum, this requirement may not apply if
Union or national law deems it excessive.
High-risk AI systems must operate consistently throughout their lifecycle and achieve a suitable level of
accuracy,
robustness, and
cybersecurity based on their intended use and current best practices. The
Commission and relevant organizations should focus on reducing risks and negative impacts of
AI systems.
Performance metrics should be clearly stated in the user instructions, and
providers should communicate this information to
users in a straightforward manner to avoid confusion or misleading claims.
Union law on legal metrology, including
Directives 2014/31/EU and 2014/32/EU, aims to ensure measurement
accuracy and promote
transparency and fairness in commercial transactions. The
Commission should work with relevant
stakeholders, such as
metrology and benchmarking authorities, to develop
benchmarks and measurement methods for
AI systems. They should also collaborate with
international partners on metrology and relevant
AI measurement indicators.
one or more entities and include the person operating or using the
system. This requirement should not pose unnecessary burden or delays and it could be sufficient that the separate
verifications by the different persons are automatically recorded in the logs generated by the system. Given the
specificities of the areas of law enforcement, migration, border control and asylum, this requirement should not
apply where Union or national law considers the application of that requirement to be disproportionate.
(74)
High-risk AI systems should perform consistently throughout their lifecycle and meet an appropriate level of
accuracy, robustness and cybersecurity, in light of their intended purpose and in accordance with the generally
acknowledged state of the art. The Commission and relevant organisations and stakeholders are encouraged to take
due consideration of the mitigation of risks and the negative impacts of the AI system. The expected level of
performance metrics should be declared in the accompanying instructions of use. Providers are urged to
communicate that information to deployers in a clear and easily understandable way, free of misunderstandings or
misleading statements. Union law on legal metrology, including Directives 2014/31/EU (35) and 2014/32/EU (36) of
the European Parliament and of the Council, aims to ensure the accuracy of measurements and to help the
transparency and fairness of commercial transactions. In that context, in cooperation with relevant stakeholders and
organisation, such as metrology and benchmarking authorities, the Commission should encourage, as appropriate,
the development of benchmarks and measurement methodologies for AI systems. In doing so, the Commission
should take note and collaborate with international partners working on metrology and relevant measurement
indicators relating to AI.
OJ L, 12.7.
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The
Commission is working on creating
benchmarks and measurement methods for
AI systems. They should collaborate with
international partners who are also focused on metrology and relevant
AI measurement indicators.
The
European Parliament and Council's
Directive 2014/31/EU, dated February 26, 2014, aims to harmonize laws across
Member States regarding the market availability of non-automatic weighing instruments. Similarly,
Directive 2014/32/EU, also from February 26, 2014, focuses on harmonizing laws for measuring instruments.
For
high-risk AI systems, technical
robustness is crucial. These systems must be able to withstand harmful or undesirable behaviors that may arise from their limitations or the environments they operate in, such as errors or unexpected situations. To ensure this
robustness, both technical and organizational measures should be implemented. This includes designing solutions that can prevent or reduce harmful behaviors, such as mechanisms that allow the system to safely stop functioning when anomalies occur or when it operates outside set limits. Failing to address these risks could lead to safety issues or violations of
fundamental rights, such as making incorrect decisions or producing biased outputs.
the development of benchmarks and measurement methodologies for AI systems. In doing so, the Commission
should take note and collaborate with international partners working on metrology and relevant measurement
indicators relating to AI.
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(35)
Directive 2014/31/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the
Member States relating to the making available on the market of non-automatic weighing instruments (OJ L 96, 29.3.2014, p. 107).
(36)
Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the
Member States relating to the making available on the market of measuring instruments (OJ L 96, 29.3.2014, p. 149).
(75)
Technical robustness is a key requirement for high-risk AI systems. They should be resilient in relation to harmful or
otherwise undesirable behaviour that may result from limitations within the systems or the environment in which
the systems operate (e.g. errors, faults, inconsistencies, unexpected situations). Therefore, technical and
organisational measures should be taken to ensure robustness of high-risk AI systems, for example by designing
and developing appropriate technical solutions to prevent or minimise harmful or otherwise undesirable behaviour.
Those technical solution may include for instance mechanisms enabling the system to safely interrupt its operation
(fail-safe plans) in the presence of certain anomalies or when operation takes place outside certain predetermined
boundaries. Failure to protect against these risks could lead to safety impacts or negatively affect the fundamental
rights, for example due to erroneous decisions or wrong or biased outputs generated by the AI system.
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Certain issues can arise when operations occur outside specific limits. If these risks are not managed, it could lead to safety problems or violate
fundamental rights, such as making incorrect decisions or producing biased results from the
AI system.
Cybersecurity is essential for protecting
AI systems from malicious attacks that could change how they operate, affect their performance, or compromise their security. Cyberattacks can target specific
AI components, like
training data (through
data poisoning) or trained models (using adversarial attacks or membership inference), or exploit weaknesses in the
AI system's digital assets or the underlying information and communication technology (ICT) infrastructure. To ensure adequate
cybersecurity for
high-risk AI systems,
providers must implement appropriate security measures, considering the ICT infrastructure as needed.
High-risk AI systems that comply with the
European Parliament and Council's regulations on
cybersecurity for digital products can meet the
cybersecurity requirements of this
Regulation by adhering to the essential
cybersecurity standards outlined in that
regulation. If these
high-risk AI systems meet the essential requirements of the
cybersecurity regulation, they will be considered compliant with the
cybersecurity standards of this
Regulation, as long as this compliance is confirmed in the
EU declaration of conformity or relevant parts of it issued under that
regulation.
certain anomalies or when operation takes place outside certain predetermined
boundaries. Failure to protect against these risks could lead to safety impacts or negatively affect the fundamental
rights, for example due to erroneous decisions or wrong or biased outputs generated by the AI system.
(76)
Cybersecurity plays a crucial role in ensuring that AI systems are resilient against attempts to alter their use,
behaviour, performance or compromise their security properties by malicious third parties exploiting the system’s
vulnerabilities. Cyberattacks against AI systems can leverage AI specific assets, such as training data sets (e.g. data
poisoning) or trained models (e.g. adversarial attacks or membership inference), or exploit vulnerabilities in the AI
system’s digital assets or the underlying ICT infrastructure. To ensure a level of cybersecurity appropriate to the risks,
suitable measures, such as security controls, should therefore be taken by the providers of high-risk AI systems, also
taking into account as appropriate the underlying ICT infrastructure.
(77)
Without prejudice to the requirements related to robustness and accuracy set out in this Regulation, high-risk AI
systems which fall within the scope of a regulation of the European Parliament and of the Council on horizontal
cybersecurity requirements for products with digital elements, in accordance with that regulation may demonstrate
compliance with the cybersecurity requirements of this Regulation by fulfilling the essential cybersecurity
requirements set out in that regulation. When high-risk AI systems fulfil the essential requirements of a regulation of
the European Parliament and of the Council on horizontal cybersecurity requirements for products with digital
elements, they should be deemed compliant with the cybersecurity requirements set out in this Regulation in so far
as the achievement of those requirements is demonstrated in the EU declaration of conformity or parts thereof
issued under that regulation.
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cybersecurity requirements for products with digital
elements, they should be deemed compliant with the cybersecurity requirements set out in this Regulation in so far
as the achievement of those requirements is demonstrated in the EU declaration of conformity or parts thereof
issued under that regulation. To that end, the assessment of the cybersecurity risks, associated to a product with
digital elements classified as high-risk AI system according to this Regulation, carried out under a regulation of the
European Parliament and of the Council on horizontal cybersecurity requirements for products with digital
elements, should consider risks to the cyber resilience of an AI system as regards attempts by unauthorised third
parties to alter its use, behaviour or performance, including AI specific vulnerabilities such as data poisoning or
adversarial attacks, as well as, as relevant, risks to fundamental rights as required by this Regulation.
(78)
The conformity assessment procedure provided by this Regulation should apply in relation to the essential
cybersecurity requirements of a product with digital elements covered by a regulation of the European Parliament
and of the Council on horizontal cybersecurity requirements for products with digital elements and classified as
a high-risk AI system under this Regulation. However, this rule should not result in reducing the necessary level of
assurance for critical products with digital elements covered by a regulation of the European Parliament and of the
Council on horizontal cybersecurity requirements for products with digital elements. Therefore, by way of
derogation from this rule, high-risk AI systems that fall within the scope of this Regulation and are also qualified as
important and critical products with digital elements pursuant to a regulation of the European Parliament and of the
Council on horizontal cybersecurity requirements for products with digital elements and to which the conformity
assessment procedure based on internal control set out in an annex to this Regulation applies, are subject to the
conformity assessment provisions of a regulation of the European Parliament and of the Council on horizontal
cybersecurity requirements for products with digital elements insofar as the essential cybersecurity requirements of
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out in an annex to this Regulation applies, are subject to the
conformity assessment provisions of a regulation of the European Parliament and of the Council on horizontal
cybersecurity requirements for products with digital elements insofar as the essential cybersecurity requirements of
that regulation are concerned. In this case, for all the other aspects covered by this Regulation the respective
provisions on conformity assessment based on internal control set out in an annex to this Regulation should apply.
Building on the knowledge and expertise of ENISA on the cybersecurity policy and tasks assigned to ENISA under
the Regulation (EU) 2019/881 of the European Parliament and of the Council (37), the Commission should cooperate
with ENISA on issues related to cybersecurity of AI systems.
EN
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(37)
Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA (the European Union Agency
for Cybersecurity) and on information and communications technology cybersecurity certification and repealing Regulation
(EU) No 526/2013 (Cybersecurity Act) (OJ L 151, 7.6.2019, p. 15).
(79)
It is appropriate that a specific natural or legal person, defined as the provider, takes responsibility for the placing on
the market or the putting into service of a high-risk AI system, regardless of whether that natural or legal person is
the person who designed or developed the system.
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A
provider, whether an individual or a company, is responsible for bringing a
high-risk AI system to market, even if they did not design or develop it. The
European Union and its member countries are committed to protecting the rights of people with disabilities, ensuring they are not discriminated against and have equal access to information and communication technologies. As
AI systems become more prevalent, it is important to apply universal design principles to ensure that everyone, including people with disabilities, can access and use these technologies while respecting their dignity and diversity.
Providers must comply with accessibility standards, including EU Directives 2016/2102 and 2019/882, and should integrate these requirements into the design of
high-risk AI systems from the start. Additionally,
providers need to implement a strong
quality management system, follow the necessary
conformity assessment procedures, maintain proper documentation, and set up an effective
post-market monitoring system.
Providers of
high-risk AI systems that already have quality management
obligations under other EU laws can incorporate the requirements from this
regulation into their existing systems.
natural or legal person, defined as the provider, takes responsibility for the placing on
the market or the putting into service of a high-risk AI system, regardless of whether that natural or legal person is
the person who designed or developed the system.
(80)
As signatories to the United Nations Convention on the Rights of Persons with Disabilities, the Union and the
Member States are legally obliged to protect persons with disabilities from discrimination and promote their equality,
to ensure that persons with disabilities have access, on an equal basis with others, to information and
communications technologies and systems, and to ensure respect for privacy for persons with disabilities. Given the
growing importance and use of AI systems, the application of universal design principles to all new technologies and
services should ensure full and equal access for everyone potentially affected by or using AI technologies, including
persons with disabilities, in a way that takes full account of their inherent dignity and diversity. It is therefore
essential that providers ensure full compliance with accessibility requirements, including Directive (EU) 2016/2102
of the European Parliament and of the Council (38) and Directive (EU) 2019/882. Providers should ensure
compliance with these requirements by design. Therefore, the necessary measures should be integrated as much as
possible into the design of the high-risk AI system.
(81)
The provider should establish a sound quality management system, ensure the accomplishment of the required
conformity assessment procedure, draw up the relevant documentation and establish a robust post-market
monitoring system. Providers of high-risk AI systems that are subject to obligations regarding quality management
systems under relevant sectoral Union law should have the possibility to include the elements of the quality
management system provided for in this Regulation as part of the existing quality management system provided for
in that other sectoral Union law.
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Organizations that manage quality systems under relevant EU laws can incorporate elements from this
Regulation into their existing quality management systems. Future standardization efforts by the
Commission should consider how this
Regulation complements existing laws.
Public authorities using
high-risk AI systems can adopt quality management rules at the national or regional level, tailored to their specific sector and organizational structure.
To enforce this
Regulation and ensure fair competition, it is crucial that any entity operating in the EU can provide authorities with necessary compliance information about their
AI systems. Therefore, companies based outside the EU must appoint an authorized representative within the EU before offering their
AI systems. This representative is responsible for ensuring compliance for
high-risk AI systems and acts as the contact point in the EU.
Given the complexity of
AI systems and in accordance with the
New Legislative Framework, it is important to clarify the roles and responsibilities of all parties involved in the
AI value chain, including
importers and distributors, to ensure legal clarity and compliance with this
Regulation.
obligations regarding quality management
systems under relevant sectoral Union law should have the possibility to include the elements of the quality
management system provided for in this Regulation as part of the existing quality management system provided for
in that other sectoral Union law. The complementarity between this Regulation and existing sectoral Union law
should also be taken into account in future standardisation activities or guidance adopted by the Commission. Public
authorities which put into service high-risk AI systems for their own use may adopt and implement the rules for the
quality management system as part of the quality management system adopted at a national or regional level, as
appropriate, taking into account the specificities of the sector and the competences and organisation of the public
authority concerned.
(82)
To enable enforcement of this Regulation and create a level playing field for operators, and, taking into account the
different forms of making available of digital products, it is important to ensure that, under all circumstances,
a person established in the Union can provide authorities with all the necessary information on the compliance of an
AI system. Therefore, prior to making their AI systems available in the Union, providers established in third
countries should, by written mandate, appoint an authorised representative established in the Union. This authorised
representative plays a pivotal role in ensuring the compliance of the high-risk AI systems placed on the market or
put into service in the Union by those providers who are not established in the Union and in serving as their contact
person established in the Union.
(83)
In light of the nature and complexity of the value chain for AI systems and in line with the New Legislative
Framework, it is essential to ensure legal certainty and facilitate the compliance with this Regulation. Therefore, it is
necessary to clarify the role and the specific obligations of relevant operators along that value chain, such as
importers and distributors who may contribute to the development of AI systems.
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To ensure legal clarity and compliance with this
Regulation, it is important to define the roles and responsibilities of key players in the value chain, such as
importers and distributors involved in developing
AI systems. These operators may take on multiple roles simultaneously and must meet all related
obligations for each role. For instance, an
operator could be both a
distributor and an
importer at the same time.
To provide legal certainty, it should be clear that under specific conditions, any
distributor,
importer,
deployer, or
third party can be considered a
provider of a
high-risk AI system and must fulfill all relevant
obligations. This applies if they put their name or trademark on a
high-risk AI system already on the market, regardless of any contractual agreements that might assign responsibilities differently. It also applies if they make significant changes to a
high-risk AI system already available, or if they alter the intended use of a non-
high-risk AI system in a way that qualifies it as high-risk under this
Regulation. These rules should be followed alongside any specific regulations set out in certain EU harmonization laws based on the
New Legislative Framework.
ensure legal certainty and facilitate the compliance with this Regulation. Therefore, it is
necessary to clarify the role and the specific obligations of relevant operators along that value chain, such as
importers and distributors who may contribute to the development of AI systems. In certain situations those
operators could act in more than one role at the same time and should therefore fulfil cumulatively all relevant
obligations associated with those roles. For example, an operator could act as a distributor and an importer at the
same time.
(84)
To ensure legal certainty, it is necessary to clarify that, under certain specific conditions, any distributor, importer,
deployer or other third-party should be considered to be a provider of a high-risk AI system and therefore assume all
the relevant obligations. This would be the case if that party puts its name or trademark on a high-risk AI system
already placed on the market or put into service, without prejudice to contractual arrangements stipulating that the
obligations are allocated otherwise. This would also be the case if that party makes a substantial modification to
a high-risk AI system that has already been placed on the market or has already been put into service in a way that it
remains a high-risk AI system in accordance with this Regulation, or if it modifies the intended purpose of an AI
system, including a general-purpose AI system, which has not been classified as high-risk and has already been
placed on the market or put into service, in a way that the AI system becomes a high-risk AI system in accordance
with this Regulation. Those provisions should apply without prejudice to more specific provisions established in
certain Union harmonisation legislation based on the New Legislative Framework, together with which this
OJ L, 12.7.
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-risk AI system in accordance
with this Regulation. Those provisions should apply without prejudice to more specific provisions established in
certain Union harmonisation legislation based on the New Legislative Framework, together with which this
OJ L, 12.7.2024
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(38)
Directive (EU) 2016/2102 of the European Parliament and of the Council of 26 October 2016 on the accessibility of the websites
and mobile applications of public sector bodies (OJ L 327, 2.12.2016, p. 1).
Regulation should apply. For example, Article 16(2) of Regulation (EU) 2017/745, establishing that certain changes
should not be considered to be modifications of a device that could affect its compliance with the applicable
requirements, should continue to apply to high-risk AI systems that are medical devices within the meaning of that
Regulation.
(85)
General-purpose AI systems may be used as high-risk AI systems by themselves or be components of other high-risk
AI systems. Therefore, due to their particular nature and in order to ensure a fair sharing of responsibilities along the
AI value chain, the providers of such systems should, irrespective of whether they may be used as high-risk AI
systems as such by other providers or as components of high-risk AI systems and unless provided otherwise under
this Regulation, closely cooperate with the providers of the relevant high-risk AI systems to enable their compliance
with the relevant obligations under this Regulation and with the competent authorities established under this
Regulation.
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High-risk AI systems must work closely with their
providers to ensure they meet the requirements of this
Regulation and cooperate with the relevant authorities. If the original
provider of an
AI system is no longer considered the
provider under this
Regulation, and they have not explicitly stated that the
AI system has changed to a high-risk category, the former
provider must still cooperate. They need to share necessary information and provide technical support to help meet the
obligations of this
Regulation, especially regarding compliance assessments for
high-risk AI systems. Additionally, if a
high-risk AI system is part of a product covered by
Union harmonization laws, the
product manufacturer must ensure that the
AI system within the product complies with this
Regulation. Throughout the
AI value chain, various parties contribute
AI systems, tools, services, and components for different purposes, such as
model training, testing, and integration into software.
of high-risk AI systems and unless provided otherwise under
this Regulation, closely cooperate with the providers of the relevant high-risk AI systems to enable their compliance
with the relevant obligations under this Regulation and with the competent authorities established under this
Regulation.
(86)
Where, under the conditions laid down in this Regulation, the provider that initially placed the AI system on the
market or put it into service should no longer be considered to be the provider for the purposes of this Regulation,
and when that provider has not expressly excluded the change of the AI system into a high-risk AI system, the
former provider should nonetheless closely cooperate and make available the necessary information and provide the
reasonably expected technical access and other assistance that are required for the fulfilment of the obligations set
out in this Regulation, in particular regarding the compliance with the conformity assessment of high-risk AI
systems.
(87)
In addition, where a high-risk AI system that is a safety component of a product which falls within the scope of
Union harmonisation legislation based on the New Legislative Framework is not placed on the market or put into
service independently from the product, the product manufacturer defined in that legislation should comply with
the obligations of the provider established in this Regulation and should, in particular, ensure that the AI system
embedded in the final product complies with the requirements of this Regulation.
(88)
Along the AI value chain multiple parties often supply AI systems, tools and services but also components or
processes that are incorporated by the provider into the AI system with various objectives, including the model
training, model retraining, model testing and evaluation, integration into software, or other aspects of model
development.
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Providers of
high-risk AI systems rely on various components and processes from third parties for tasks like
model training, testing, and integration into software. These third parties play a crucial role in the
AI value chain and must provide the necessary information and support to the
provider through a written agreement. This support should help the
provider meet regulatory
obligations while protecting the third parties'
intellectual property rights.
Third parties that offer tools, services, or
AI components under a free and
open-source license are not required to follow the same regulations as those that apply to the
AI value chain, especially towards the
providers using their offerings. However, developers of these free and open-source resources are encouraged to adopt standard documentation practices, like
model cards and
data sheets, to enhance information sharing and promote trustworthy
AI systems in the EU.
The
Commission may create and suggest voluntary contract terms for cooperation between
providers of
high-risk AI systems and third parties supplying necessary tools and services. These terms should consider specific sector requirements and business cases.
and services but also components or
processes that are incorporated by the provider into the AI system with various objectives, including the model
training, model retraining, model testing and evaluation, integration into software, or other aspects of model
development. Those parties have an important role to play in the value chain towards the provider of the high-risk
AI system into which their AI systems, tools, services, components or processes are integrated, and should provide
by written agreement this provider with the necessary information, capabilities, technical access and other assistance
based on the generally acknowledged state of the art, in order to enable the provider to fully comply with the
obligations set out in this Regulation, without compromising their own intellectual property rights or trade secrets.
(89)
Third parties making accessible to the public tools, services, processes, or AI components other than
general-purpose AI models, should not be mandated to comply with requirements targeting the responsibilities
along the AI value chain, in particular towards the provider that has used or integrated them, when those tools,
services, processes, or AI components are made accessible under a free and open-source licence. Developers of free
and open-source tools, services, processes, or AI components other than general-purpose AI models should be
encouraged to implement widely adopted documentation practices, such as model cards and data sheets, as a way to
accelerate information sharing along the AI value chain, allowing the promotion of trustworthy AI systems in the
Union.
(90)
The Commission could develop and recommend voluntary model contractual terms between providers of high-risk
AI systems and third parties that supply tools, services, components or processes that are used or integrated in
high-risk AI systems, to facilitate the cooperation along the value chain. When developing voluntary model
contractual terms, the Commission should also take into account possible contractual requirements applicable in
specific sectors or business cases.
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High-risk AI systems require specific processes to ensure cooperation throughout the value chain. When creating voluntary model contracts, the
Commission should consider any contractual requirements that may apply to specific sectors or business cases.
Due to the potential risks to safety and
fundamental rights associated with
AI systems, it is important to establish clear responsibilities for those deploying these systems. Deployers must take appropriate technical and organizational measures to ensure that
high-risk AI systems are used according to the provided instructions. They also have
obligations regarding monitoring the
AI systems' performance and maintaining proper records. Additionally, deployers must ensure that the individuals responsible for following the instructions and overseeing the
AI systems have the necessary skills, training, and authority to perform their tasks effectively. These
obligations do not replace other legal responsibilities that deployers may have under
Union or national law regarding
high-risk AI systems.
This
Regulation does not affect employers'
obligations to inform or consult workers or their representatives under
Union or national law, including
Directive 2002/14/EC. It is essential to keep workers and their representatives informed about the planned use of
high-risk AI systems in the workplace, especially when other legal requirements for information and consultation are not met.
processes that are used or integrated in
high-risk AI systems, to facilitate the cooperation along the value chain. When developing voluntary model
contractual terms, the Commission should also take into account possible contractual requirements applicable in
specific sectors or business cases.
(91)
Given the nature of AI systems and the risks to safety and fundamental rights possibly associated with their use,
including as regards the need to ensure proper monitoring of the performance of an AI system in a real-life setting, it
is appropriate to set specific responsibilities for deployers. Deployers should in particular take appropriate technical
and organisational measures to ensure they use high-risk AI systems in accordance with the instructions of use and
certain other obligations should be provided for with regard to monitoring of the functioning of the AI systems and
with regard to record-keeping, as appropriate. Furthermore, deployers should ensure that the persons assigned to
implement the instructions for use and human oversight as set out in this Regulation have the necessary
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competence, in particular an adequate level of AI literacy, training and authority to properly fulfil those tasks. Those
obligations should be without prejudice to other deployer obligations in relation to high-risk AI systems under
Union or national law.
(92)
This Regulation is without prejudice to obligations for employers to inform or to inform and consult workers or
their representatives under Union or national law and practice, including Directive 2002/14/EC of the European
Parliament and of the Council (39), on decisions to put into service or use AI systems. It remains necessary to ensure
information of workers and their representatives on the planned deployment of high-risk AI systems at the
workplace where the conditions for those information or information and consultation obligations in other legal
instruments are not fulfilled.
Show original text
It is important to keep workers and their representatives informed about the planned use of
high-risk AI systems in the workplace, especially when existing legal requirements for information and consultation are not met. This right to information is essential for protecting
fundamental rights, which is the main goal of this
Regulation. Therefore, this
Regulation will include a requirement for providing such information, without affecting any current rights of workers.
High-risk AI systems can pose risks not only based on their design but also on how they are used. Those who deploy these systems play a crucial role in safeguarding
fundamental rights, in addition to the responsibilities of the
AI system providers. Deployers have a better understanding of how the
AI system will be used and can identify significant risks that may not have been anticipated during development, especially concerning the context of use and the individuals or groups affected, including vulnerable populations.
Deployers of
high-risk AI systems, as listed in an annex to this
Regulation, must also inform individuals when decisions are made about them or with their assistance. This information should include the purpose of the
AI system and the types of decisions it makes. Additionally, deployers must inform individuals of their right to an explanation as outlined in this
Regulation. For
high-risk AI systems used in
law enforcement, this obligation must be followed according to
Article 13 of Directive (EU) 2016/680.
AI systems. It remains necessary to ensure
information of workers and their representatives on the planned deployment of high-risk AI systems at the
workplace where the conditions for those information or information and consultation obligations in other legal
instruments are not fulfilled. Moreover, such information right is ancillary and necessary to the objective of
protecting fundamental rights that underlies this Regulation. Therefore, an information requirement to that effect
should be laid down in this Regulation, without affecting any existing rights of workers.
(93)
Whilst risks related to AI systems can result from the way such systems are designed, risks can as well stem from
how such AI systems are used. Deployers of high-risk AI system therefore play a critical role in ensuring that
fundamental rights are protected, complementing the obligations of the provider when developing the AI system.
Deployers are best placed to understand how the high-risk AI system will be used concretely and can therefore
identify potential significant risks that were not foreseen in the development phase, due to a more precise knowledge
of the context of use, the persons or groups of persons likely to be affected, including vulnerable groups. Deployers
of high-risk AI systems listed in an annex to this Regulation also play a critical role in informing natural persons and
should, when they make decisions or assist in making decisions related to natural persons, where applicable, inform
the natural persons that they are subject to the use of the high-risk AI system. This information should include the
intended purpose and the type of decisions it makes. The deployer should also inform the natural persons about
their right to an explanation provided under this Regulation. With regard to high-risk AI systems used for law
enforcement purposes, that obligation should be implemented in accordance with Article 13 of Directive (EU)
2016/680.
Show original text
Individuals have the right to receive an explanation under this
Regulation. For
high-risk AI systems used in
law enforcement, this obligation must follow
Article 13 of Directive (EU) 2016/680. Any use of
biometric data for
AI-based identification in
law enforcement must comply with
Article 10 of Directive (EU) 2016/680. This means such processing is only allowed when absolutely necessary, with proper
safeguards for the rights of individuals, and must be authorized by EU or
Member State law. When authorized, it must also adhere to principles in
Article 4(1) of
Directive (EU) 2016/680, which include legality, fairness,
transparency, purpose limitation,
accuracy, and storage limitation. Additionally, while respecting applicable EU laws, particularly
Regulation (EU) 2016/679 and
Directive (EU) 2016/680, the use of
post-remote biometric identification systems, which can be intrusive, must have
safeguards in place. These systems should be used in a way that is proportionate, legitimate, and strictly necessary, targeting specific individuals, locations, and timeframes, and based on a closed set of legally obtained
video footage. They should not be used for indiscriminate surveillance in
law enforcement. The conditions for using post-
remote biometric identification must not allow for bypassing the strict rules against real-time
remote biometric identification.
persons about
their right to an explanation provided under this Regulation. With regard to high-risk AI systems used for law
enforcement purposes, that obligation should be implemented in accordance with Article 13 of Directive (EU)
2016/680.
(94)
Any processing of biometric data involved in the use of AI systems for biometric identification for the purpose of
law enforcement needs to comply with Article 10 of Directive (EU) 2016/680, that allows such processing only
where strictly necessary, subject to appropriate safeguards for the rights and freedoms of the data subject, and where
authorised by Union or Member State law. Such use, when authorised, also needs to respect the principles laid down
in Article 4 (1) of Directive (EU) 2016/680 including lawfulness, fairness and transparency, purpose limitation,
accuracy and storage limitation.
(95)
Without prejudice to applicable Union law, in particular Regulation (EU) 2016/679 and Directive (EU) 2016/680,
considering the intrusive nature of post-remote biometric identification systems, the use of post-remote biometric
identification systems should be subject to safeguards. Post-remote biometric identification systems should always be
used in a way that is proportionate, legitimate and strictly necessary, and thus targeted, in terms of the individuals to
be identified, the location, temporal scope and based on a closed data set of legally acquired video footage. In any
case, post-remote biometric identification systems should not be used in the framework of law enforcement to lead
to indiscriminate surveillance. The conditions for post-remote biometric identification should in any case not
provide a basis to circumvent the conditions of the prohibition and strict exceptions for real time remote biometric
identification.
Show original text
framework of law enforcement to lead
to indiscriminate surveillance. The conditions for post-remote biometric identification should in any case not
provide a basis to circumvent the conditions of the prohibition and strict exceptions for real time remote biometric
identification.
(96)
In order to efficiently ensure that fundamental rights are protected, deployers of high-risk AI systems that are bodies
governed by public law, or private entities providing public services and deployers of certain high-risk AI systems
listed in an annex to this Regulation, such as banking or insurance entities, should carry out a fundamental rights
impact assessment prior to putting it into use. Services important for individuals that are of public nature may also
be provided by private entities. Private entities providing such public services are linked to tasks in the public interest
such as in the areas of education, healthcare, social services, housing, administration of justice. The aim of the
fundamental rights impact assessment is for the deployer to identify the specific risks to the rights of individuals or
groups of individuals likely to be affected, identify measures to be taken in the case of a materialisation of those risks.
The impact assessment should be performed prior to deploying the high-risk AI system, and should be updated
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(39)
Directive 2002/14/EC of the European Parliament and of the Council of 11 March 2002 establishing a general framework for
informing and consulting employees in the European Community (OJ L 80, 23.3.2002, p. 29).
when the deployer considers that any of the relevant factors have changed.
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The document establishes a framework for informing and consulting employees in the European Community (
OJ L 80, 23.3.2002, p. 29). When the
deployer of a
high-risk AI system believes that relevant factors have changed, they must conduct an
impact assessment. This assessment should identify how the
AI system will be used, including the duration and frequency of its use, as well as the specific individuals or groups that may be affected. It should also identify potential risks that could harm the
fundamental rights of these individuals or groups. The
deployer must consider all relevant information, including guidance from the
AI system's
provider. Based on the identified risks, the
deployer should establish measures to address these risks, such as governance arrangements for
human oversight, complaint handling, and redress procedures. After completing the
impact assessment, the
deployer must notify the relevant
market surveillance authority. If necessary, especially in public sector applications, deployers should involve
stakeholders, including representatives of affected groups, independent experts, and civil society organizations, in the assessment process and in designing risk mitigation measures.
2 establishing a general framework for
informing and consulting employees in the European Community (OJ L 80, 23.3.2002, p. 29).
when the deployer considers that any of the relevant factors have changed. The impact assessment should identify
the deployer’s relevant processes in which the high-risk AI system will be used in line with its intended purpose, and
should include a description of the period of time and frequency in which the system is intended to be used as well
as of specific categories of natural persons and groups who are likely to be affected in the specific context of use. The
assessment should also include the identification of specific risks of harm likely to have an impact on the
fundamental rights of those persons or groups. While performing this assessment, the deployer should take into
account information relevant to a proper assessment of the impact, including but not limited to the information
given by the provider of the high-risk AI system in the instructions for use. In light of the risks identified, deployers
should determine measures to be taken in the case of a materialisation of those risks, including for example
governance arrangements in that specific context of use, such as arrangements for human oversight according to the
instructions of use or, complaint handling and redress procedures, as they could be instrumental in mitigating risks
to fundamental rights in concrete use-cases. After performing that impact assessment, the deployer should notify the
relevant market surveillance authority. Where appropriate, to collect relevant information necessary to perform the
impact assessment, deployers of high-risk AI system, in particular when AI systems are used in the public sector,
could involve relevant stakeholders, including the representatives of groups of persons likely to be affected by the AI
system, independent experts, and civil society organisations in conducting such impact assessments and designing
measures to be taken in the case of materialisation of the risks.
Show original text
Relevant
stakeholders, including representatives from groups likely to be affected by
AI systems, independent experts, and civil society organizations, should be involved in impact assessments and in designing measures to address potential risks. The
European Artificial Intelligence Office (
AI Office) will create a questionnaire template to help ensure compliance and reduce the administrative burden for those deploying
AI.
The term '
general-purpose AI models' needs a clear definition, distinct from '
AI systems,' to provide legal clarity. This definition should focus on the main features of
general-purpose AI models, particularly their ability to perform a wide variety of tasks. These models are usually trained on large datasets using methods like self-supervised, unsupervised, or
reinforcement learning. They can be made available in different ways, such as through libraries, APIs, direct downloads, or physical copies, and can be modified into new models.
While
AI models are crucial for
AI systems, they are not complete systems by themselves. They need additional components, like a
user interface, to function as
AI systems. This
regulation outlines specific rules for
general-purpose AI models, especially those that pose
systemic risks, which also apply when these models are part of an
AI system.
Providers of
general-purpose AI models must comply with these
obligations once the models are available on the market.
relevant stakeholders, including the representatives of groups of persons likely to be affected by the AI
system, independent experts, and civil society organisations in conducting such impact assessments and designing
measures to be taken in the case of materialisation of the risks. The European Artificial Intelligence Office (AI Office)
should develop a template for a questionnaire in order to facilitate compliance and reduce the administrative burden
for deployers.
(97)
The notion of general-purpose AI models should be clearly defined and set apart from the notion of AI systems to
enable legal certainty. The definition should be based on the key functional characteristics of a general-purpose AI
model, in particular the generality and the capability to competently perform a wide range of distinct tasks. These
models are typically trained on large amounts of data, through various methods, such as self-supervised,
unsupervised or reinforcement learning. General-purpose AI models may be placed on the market in various ways,
including through libraries, application programming interfaces (APIs), as direct download, or as physical copy.
These models may be further modified or fine-tuned into new models. Although AI models are essential
components of AI systems, they do not constitute AI systems on their own. AI models require the addition of further
components, such as for example a user interface, to become AI systems. AI models are typically integrated into and
form part of AI systems. This Regulation provides specific rules for general-purpose AI models and for
general-purpose AI models that pose systemic risks, which should apply also when these models are integrated or
form part of an AI system. It should be understood that the obligations for the providers of general-purpose AI
models should apply once the general-purpose AI models are placed on the market.
Show original text
The risks associated with
AI models should also apply when these models are part of an
AI system.
Providers of
general-purpose AI models must meet their
obligations once these models are available on the market. If a
provider integrates their own model into an
AI system that is sold or used, that model is considered to be on the market, and the
obligations for models will still apply alongside those for
AI systems. However, these
obligations do not apply if the model is used only for
internal processes that do not affect third-party products or services and do not impact individual rights. Due to their potential for significant negative effects,
general-purpose AI models that pose
systemic risks must always comply with the relevant regulations. Additionally, models used solely for research, development, and prototyping before being marketed are not covered by these
obligations, but they must comply with regulations once they are placed on the market. Models with at least one billion
parameters, trained on large datasets using
self-supervision, are considered to have significant generality and can perform a wide range of tasks.
Large generative AI models are a prime example of
general-purpose AI models, as they can flexibly generate various types of content, including text, audio, images, and video, suitable for many different tasks.
risks, which should apply also when these models are integrated or
form part of an AI system. It should be understood that the obligations for the providers of general-purpose AI
models should apply once the general-purpose AI models are placed on the market. When the provider of
a general-purpose AI model integrates an own model into its own AI system that is made available on the market or
put into service, that model should be considered to be placed on the market and, therefore, the obligations in this
Regulation for models should continue to apply in addition to those for AI systems. The obligations laid down for
models should in any case not apply when an own model is used for purely internal processes that are not essential
for providing a product or a service to third parties and the rights of natural persons are not affected. Considering
their potential significantly negative effects, the general-purpose AI models with systemic risk should always be
subject to the relevant obligations under this Regulation. The definition should not cover AI models used before their
placing on the market for the sole purpose of research, development and prototyping activities. This is without
prejudice to the obligation to comply with this Regulation when, following such activities, a model is placed on the
market.
(98)
Whereas the generality of a model could, inter alia, also be determined by a number of parameters, models with at
least a billion of parameters and trained with a large amount of data using self-supervision at scale should be
considered to display significant generality and to competently perform a wide range of distinctive tasks.
(99)
Large generative AI models are a typical example for a general-purpose AI model, given that they allow for flexible
generation of content, such as in the form of text, audio, images or video, that can readily accommodate a wide
range of distinctive tasks.
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AI models are a common example of general-purpose
AI because they can create various types of content, including text, audio, images, and video, for many different tasks. When a
general-purpose AI model is part of an
AI system, that system is considered a
general-purpose AI system if it can serve multiple functions. Such a system can be used on its own or integrated into other
AI systems.
Providers of
general-purpose AI models have important responsibilities in the
AI value chain. Their models often serve as the foundation for various downstream systems created by other
providers. These downstream
providers need to understand the models and their capabilities to integrate them into their products and comply with regulations. Therefore, there should be clear
transparency measures, including maintaining up-to-date documentation and providing information about the
general-purpose AI model for downstream
providers. The model
provider must prepare and keep
technical documentation current, which should be available to the
AI Office and
national authorities upon request. Specific elements that must be included in this documentation will be outlined in annexes to this
Regulation, and the
Commission can update these annexes as technology evolves.
AI models are a typical example for a general-purpose AI model, given that they allow for flexible
generation of content, such as in the form of text, audio, images or video, that can readily accommodate a wide
range of distinctive tasks.
(100)
When a general-purpose AI model is integrated into or forms part of an AI system, this system should be considered
to be general-purpose AI system when, due to this integration, this system has the capability to serve a variety of
purposes. A general-purpose AI system can be used directly, or it may be integrated into other AI systems.
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(101)
Providers of general-purpose AI models have a particular role and responsibility along the AI value chain, as the
models they provide may form the basis for a range of downstream systems, often provided by downstream
providers that necessitate a good understanding of the models and their capabilities, both to enable the integration of
such models into their products, and to fulfil their obligations under this or other regulations. Therefore,
proportionate transparency measures should be laid down, including the drawing up and keeping up to date of
documentation, and the provision of information on the general-purpose AI model for its usage by the downstream
providers. Technical documentation should be prepared and kept up to date by the general-purpose AI model
provider for the purpose of making it available, upon request, to the AI Office and the national competent
authorities. The minimal set of elements to be included in such documentation should be set out in specific annexes
to this Regulation. The Commission should be empowered to amend those annexes by means of delegated acts in
light of evolving technological developments.
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Authorities need to outline the essential elements for documentation in specific annexes to this
Regulation. The
Commission can update these annexes through delegated acts as technology evolves.
Software and
data, including models, that are released under a free and
open-source license allow
users to share, access, modify, and redistribute them freely. This can boost research and innovation and create significant growth opportunities for the
Union economy.
General-purpose AI models under such licenses should ensure
transparency by making their
parameters, model architecture, and usage information publicly available. A license is considered free and open-source if it permits
users to run, copy, distribute, study, change, and improve the software and
data, as long as the original
provider is credited and distribution terms are respected.
Free and open-source AI components include software,
data, models, tools, services, or processes of an
AI system. These components can be shared through various channels, including open repositories. However,
AI components that are sold or monetized in any way, such as through technical support or services, or that use
personal data for purposes other than improving software security, compatibility, or interoperability (except for transactions between
microenterprises), do not qualify for the exceptions granted to
free and open-source AI components.
authorities. The minimal set of elements to be included in such documentation should be set out in specific annexes
to this Regulation. The Commission should be empowered to amend those annexes by means of delegated acts in
light of evolving technological developments.
(102)
Software and data, including models, released under a free and open-source licence that allows them to be openly
shared and where users can freely access, use, modify and redistribute them or modified versions thereof, can
contribute to research and innovation in the market and can provide significant growth opportunities for the Union
economy. General-purpose AI models released under free and open-source licences should be considered to ensure
high levels of transparency and openness if their parameters, including the weights, the information on the model
architecture, and the information on model usage are made publicly available. The licence should be considered to be
free and open-source also when it allows users to run, copy, distribute, study, change and improve software and data,
including models under the condition that the original provider of the model is credited, the identical or comparable
terms of distribution are respected.
(103)
Free and open-source AI components covers the software and data, including models and general-purpose AI
models, tools, services or processes of an AI system. Free and open-source AI components can be provided through
different channels, including their development on open repositories. For the purposes of this Regulation, AI
components that are provided against a price or otherwise monetised, including through the provision of technical
support or other services, including through a software platform, related to the AI component, or the use of
personal data for reasons other than exclusively for improving the security, compatibility or interoperability of the
software, with the exception of transactions between microenterprises, should not benefit from the exceptions
provided to free and open-source AI components.
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Personal data should not be used for purposes other than improving software security, compatibility, or interoperability, except for transactions between
microenterprises. Making
AI components available in open repositories does not mean they can be monetized.
Providers of
general-purpose AI models that are released under a free and
open-source license must meet
transparency requirements unless their models pose a
systemic risk. In such cases, being transparent and open-source does not exempt them from regulatory
obligations. Additionally, releasing these models does not automatically disclose important information about the
training data or copyright compliance. Therefore, they still need to provide a summary of the training content and ensure they follow copyright laws, particularly
Article 4(3) of
Directive (EU) 2019/790.
General-purpose AI models, especially large generative ones that create text, images, and other content, offer significant innovation opportunities but also pose challenges for artists, authors, and creators regarding how their work is created, shared, and used.
use of
personal data for reasons other than exclusively for improving the security, compatibility or interoperability of the
software, with the exception of transactions between microenterprises, should not benefit from the exceptions
provided to free and open-source AI components. The fact of making AI components available through open
repositories should not, in itself, constitute a monetisation.
(104)
The providers of general-purpose AI models that are released under a free and open-source licence, and whose
parameters, including the weights, the information on the model architecture, and the information on model usage,
are made publicly available should be subject to exceptions as regards the transparency-related requirements
imposed on general-purpose AI models, unless they can be considered to present a systemic risk, in which case the
circumstance that the model is transparent and accompanied by an open-source license should not be considered to
be a sufficient reason to exclude compliance with the obligations under this Regulation. In any case, given that the
release of general-purpose AI models under free and open-source licence does not necessarily reveal substantial
information on the data set used for the training or fine-tuning of the model and on how compliance of copyright
law was thereby ensured, the exception provided for general-purpose AI models from compliance with the
transparency-related requirements should not concern the obligation to produce a summary about the content used
for model training and the obligation to put in place a policy to comply with Union copyright law, in particular to
identify and comply with the reservation of rights pursuant to Article 4(3) of Directive (EU) 2019/790 of the
European Parliament and of the Council (40).
(105)
General-purpose AI models, in particular large generative AI models, capable of generating text, images, and other
content, present unique innovation opportunities but also challenges to artists, authors, and other creators and the
way their creative content is created, distributed, used and consumed.
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Large generative AI models can create text, images, and other content, offering new opportunities and challenges for artists, authors, and creators regarding how their work is made, shared, and used. Developing these models requires access to a lot of
data, including text, images, and videos. Techniques for
text and data mining are often used to gather and analyze this content, which may be protected by copyright. To use copyrighted material, permission from the rights holder is usually needed, unless specific copyright exceptions apply.
Directive (EU) 2019/790 allows for certain reproductions and extractions of works for
text and data mining under specific conditions. Rights holders can choose to protect their works from
text and data mining, except for scientific research purposes. If rights holders have opted out,
AI model providers must get permission from them to perform
text and data mining on those works.
particular large generative AI models, capable of generating text, images, and other
content, present unique innovation opportunities but also challenges to artists, authors, and other creators and the
way their creative content is created, distributed, used and consumed. The development and training of such models
require access to vast amounts of text, images, videos and other data. Text and data mining techniques may be used
extensively in this context for the retrieval and analysis of such content, which may be protected by copyright and
related rights. Any use of copyright protected content requires the authorisation of the rightsholder concerned
unless relevant copyright exceptions and limitations apply. Directive (EU) 2019/790 introduced exceptions and
limitations allowing reproductions and extractions of works or other subject matter, for the purpose of text and data
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(40)
Directive (EU) 2019/790 of the European Parliament and of the Council of 17 April 2019 on copyright and related rights in the
Digital Single Market and amending Directives 96/9/EC and 2001/29/EC (OJ L 130, 17.5.2019, p. 92).
mining, under certain conditions. Under these rules, rightsholders may choose to reserve their rights over their
works or other subject matter to prevent text and data mining, unless this is done for the purposes of scientific
research. Where the rights to opt out has been expressly reserved in an appropriate manner, providers of
general-purpose AI models need to obtain an authorisation from rightsholders if they want to carry out text and
data mining over such works.
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Providers of
general-purpose AI models must get permission from copyright holders if they want to use text and
data from works where the right to opt out has been clearly stated. They need to follow the rules set out in the relevant regulations to ensure they respect copyright and related rights, particularly as outlined in
Article 4(3) of
Directive (EU) 2019/790. This requirement applies to all
providers placing
AI models on the market in the
European Union, regardless of where the copyright-related activities occur. This ensures fair competition, preventing any
provider from gaining an advantage by adhering to lower copyright standards than those in the EU.
To promote
transparency about the
data used to train these
AI models, including copyrighted material,
providers should create and publicly share a detailed summary of the training content. This summary should be broad enough to help copyright holders and others with legitimate interests understand and enforce their rights, while still protecting
trade secrets and confidential information. It should include information about the main
data collections used, such as large private or public databases, and provide a general explanation of other
data sources.
research. Where the rights to opt out has been expressly reserved in an appropriate manner, providers of
general-purpose AI models need to obtain an authorisation from rightsholders if they want to carry out text and
data mining over such works.
(106)
Providers that place general-purpose AI models on the Union market should ensure compliance with the relevant
obligations in this Regulation. To that end, providers of general-purpose AI models should put in place a policy to
comply with Union law on copyright and related rights, in particular to identify and comply with the reservation of
rights expressed by rightsholders pursuant to Article 4(3) of Directive (EU) 2019/790. Any provider placing
a general-purpose AI model on the Union market should comply with this obligation, regardless of the jurisdiction
in which the copyright-relevant acts underpinning the training of those general-purpose AI models take place. This
is necessary to ensure a level playing field among providers of general-purpose AI models where no provider should
be able to gain a competitive advantage in the Union market by applying lower copyright standards than those
provided in the Union.
(107)
In order to increase transparency on the data that is used in the pre-training and training of general-purpose AI
models, including text and data protected by copyright law, it is adequate that providers of such models draw up and
make publicly available a sufficiently detailed summary of the content used for training the general-purpose AI
model. While taking into due account the need to protect trade secrets and confidential business information, this
summary should be generally comprehensive in its scope instead of technically detailed to facilitate parties with
legitimate interests, including copyright holders, to exercise and enforce their rights under Union law, for example by
listing the main data collections or sets that went into training the model, such as large private or public databases or
data archives, and by providing a narrative explanation about other data sources used.
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Providers of
general-purpose AI models must follow
Union law by clearly listing the main
data collections used to train their models, such as large private or public databases. They should also provide a narrative explanation of any other
data sources used. The
AI Office will create a simple template for this summary to help
providers present the information effectively.
The
AI Office is responsible for ensuring that these
providers have a policy in place to comply with
Union copyright law and that they publicly share a summary of the content used for training. However, the
AI Office will not conduct detailed checks on each piece of
training data for copyright compliance. This
regulation does not change existing copyright laws under
Union law.
Compliance requirements for
AI model providers should be appropriate to the type of
provider. Individuals developing or using models for personal or non-scientific research do not need to comply, but they are encouraged to do so voluntarily. Compliance should also consider the size of the
provider, allowing smaller businesses and startups to meet requirements in a cost-effective way. If a model is modified or fine-tuned, the compliance
obligations should only apply to those changes, such as updating
technical documentation with information about new
training data sources.
and enforce their rights under Union law, for example by
listing the main data collections or sets that went into training the model, such as large private or public databases or
data archives, and by providing a narrative explanation about other data sources used. It is appropriate for the AI
Office to provide a template for the summary, which should be simple, effective, and allow the provider to provide
the required summary in narrative form.
(108)
With regard to the obligations imposed on providers of general-purpose AI models to put in place a policy to
comply with Union copyright law and make publicly available a summary of the content used for the training, the AI
Office should monitor whether the provider has fulfilled those obligations without verifying or proceeding to
a work-by-work assessment of the training data in terms of copyright compliance. This Regulation does not affect
the enforcement of copyright rules as provided for under Union law.
(109)
Compliance with the obligations applicable to the providers of general-purpose AI models should be commensurate
and proportionate to the type of model provider, excluding the need for compliance for persons who develop or use
models for non-professional or scientific research purposes, who should nevertheless be encouraged to voluntarily
comply with these requirements. Without prejudice to Union copyright law, compliance with those obligations
should take due account of the size of the provider and allow simplified ways of compliance for SMEs, including
start-ups, that should not represent an excessive cost and not discourage the use of such models. In the case of
a modification or fine-tuning of a model, the obligations for providers of general-purpose AI models should be
limited to that modification or fine-tuning, for example by complementing the already existing technical
documentation with information on the modifications, including new training data sources, as a means to comply
with the value chain obligations provided in this Regulation.
Show original text
Modifications to
AI models should be limited to adjustments that enhance existing
technical documentation, such as adding information about new
training data sources, to meet the requirements of the
regulation.
General-purpose AI models can create
systemic risks, which may include negative impacts on major accidents, disruptions in critical sectors, and serious threats to public
health and safety. They can also affect democratic processes and
public security, and lead to the spread of illegal, false, or discriminatory content. These risks increase with the model's capabilities and reach, and can occur throughout the model's lifecycle. Factors influencing these risks include misuse, reliability, fairness, security, autonomy, access to tools, and distribution strategies. International discussions have highlighted the importance of addressing risks from intentional misuse or unintended control issues, as well as risks related to chemical, biological, radiological, and nuclear threats, which could lower barriers for weapon development. Additionally, there are concerns about offensive cyber capabilities, the impact of
AI on physical systems and
critical infrastructure, and the potential for models to replicate themselves or train other models, which can lead to harmful biases.
be
limited to that modification or fine-tuning, for example by complementing the already existing technical
documentation with information on the modifications, including new training data sources, as a means to comply
with the value chain obligations provided in this Regulation.
(110)
General-purpose AI models could pose systemic risks which include, but are not limited to, any actual or reasonably
foreseeable negative effects in relation to major accidents, disruptions of critical sectors and serious consequences to
public health and safety; any actual or reasonably foreseeable negative effects on democratic processes, public and
economic security; the dissemination of illegal, false, or discriminatory content. Systemic risks should be understood
to increase with model capabilities and model reach, can arise along the entire lifecycle of the model, and are
influenced by conditions of misuse, model reliability, model fairness and model security, the level of autonomy of
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the model, its access to tools, novel or combined modalities, release and distribution strategies, the potential to
remove guardrails and other factors. In particular, international approaches have so far identified the need to pay
attention to risks from potential intentional misuse or unintended issues of control relating to alignment with
human intent; chemical, biological, radiological, and nuclear risks, such as the ways in which barriers to entry can be
lowered, including for weapons development, design acquisition, or use; offensive cyber capabilities, such as the
ways in vulnerability discovery, exploitation, or operational use can be enabled; the effects of interaction and tool
use, including for example the capacity to control physical systems and interfere with critical infrastructure; risks
from models of making copies of themselves or ‘self-replicating’ or training other models; the ways in which models
can give rise to harmful bias
Show original text
There are several risks associated with
general-purpose AI models. These include the ability to control physical systems and disrupt
critical infrastructure, the potential for models to create copies of themselves or train other models, and the risk of harmful bias and
discrimination that could affect individuals and communities. Additionally, these models can spread disinformation and threaten privacy, which poses risks to democratic values and human rights. A single event involving these models could trigger a chain reaction with serious negative consequences, potentially impacting an entire city or community.
To address these concerns, it is important to develop a method for classifying
general-purpose AI models that carry
systemic risks. A model should be classified as having
systemic risks if it possesses
high-impact capabilities, which can be assessed using appropriate technical tools and methodologies, or if it significantly affects the
internal market due to its reach.
High-impact capabilities refer to those that are equal to or greater than those found in the most advanced
general-purpose AI models. The full extent of a model's capabilities may only be fully understood after it is on the market or when
users interact with it.
At the time this
regulation takes effect, one way to estimate a model's capabilities is by measuring the total amount of
computation used during its training, expressed in
floating point operations. This includes all computations involved in enhancing the model's capabilities before it is deployed, such as
pre-training, generating synthetic
data, and
fine-tuning. Therefore, a specific threshold for
floating point operations should be established. If a
general-purpose AI model meets this threshold, it will be presumed to have
systemic risks.
, including for example the capacity to control physical systems and interfere with critical infrastructure; risks
from models of making copies of themselves or ‘self-replicating’ or training other models; the ways in which models
can give rise to harmful bias and discrimination with risks to individuals, communities or societies; the facilitation of
disinformation or harming privacy with threats to democratic values and human rights; risk that a particular event
could lead to a chain reaction with considerable negative effects that could affect up to an entire city, an entire
domain activity or an entire community.
(111)
It is appropriate to establish a methodology for the classification of general-purpose AI models as general-purpose
AI model with systemic risks. Since systemic risks result from particularly high capabilities, a general-purpose AI
model should be considered to present systemic risks if it has high-impact capabilities, evaluated on the basis of
appropriate technical tools and methodologies, or significant impact on the internal market due to its reach.
High-impact capabilities in general-purpose AI models means capabilities that match or exceed the capabilities
recorded in the most advanced general-purpose AI models. The full range of capabilities in a model could be better
understood after its placing on the market or when deployers interact with the model. According to the state of the
art at the time of entry into force of this Regulation, the cumulative amount of computation used for the training of
the general-purpose AI model measured in floating point operations is one of the relevant approximations for model
capabilities. The cumulative amount of computation used for training includes the computation used across the
activities and methods that are intended to enhance the capabilities of the model prior to deployment, such as
pre-training, synthetic data generation and fine-tuning. Therefore, an initial threshold of floating point operations
should be set, which, if met by a general-purpose AI model, leads to a presumption that the model is
a general-purpose AI model with systemic risks.
Show original text
To ensure safety in
AI development, we need to establish a baseline for the number of
floating point operations a
general-purpose AI model must meet. If a model reaches this threshold, it is presumed to have
systemic risks. This threshold should be updated regularly to keep pace with advancements in technology and industry, such as better algorithms or more efficient
hardware. Additionally, we should create
benchmarks and indicators to assess the model's capabilities. The
AI Office should collaborate with scientists, industry leaders, civil society, and other experts to develop these standards. The thresholds and assessment tools should effectively predict the generality, capabilities, and
systemic risks of
general-purpose AI models, considering factors like market placement and user impact. Furthermore, the
Commission should have the authority to individually classify a model as a
general-purpose AI model with
systemic risks if it meets or exceeds the established threshold. This classification will be based on a comprehensive evaluation of specific criteria outlined in the
regulation, including the quality and size of the
training data, the number of
users, the model's input and output methods, its autonomy, scalability, and available tools. If a
provider believes their model has been incorrectly classified, they can request a reassessment from the
Commission. Lastly, we need to clarify the process for classifying
general-purpose AI models with
systemic risks.
data generation and fine-tuning. Therefore, an initial threshold of floating point operations
should be set, which, if met by a general-purpose AI model, leads to a presumption that the model is
a general-purpose AI model with systemic risks. This threshold should be adjusted over time to reflect technological
and industrial changes, such as algorithmic improvements or increased hardware efficiency, and should be
supplemented with benchmarks and indicators for model capability. To inform this, the AI Office should engage
with the scientific community, industry, civil society and other experts. Thresholds, as well as tools and benchmarks
for the assessment of high-impact capabilities, should be strong predictors of generality, its capabilities and
associated systemic risk of general-purpose AI models, and could take into account the way the model will be placed
on the market or the number of users it may affect. To complement this system, there should be a possibility for the
Commission to take individual decisions designating a general-purpose AI model as a general-purpose AI model
with systemic risk if it is found that such model has capabilities or an impact equivalent to those captured by the set
threshold. That decision should be taken on the basis of an overall assessment of the criteria for the designation of
a general-purpose AI model with systemic risk set out in an annex to this Regulation, such as quality or size of the
training data set, number of business and end users, its input and output modalities, its level of autonomy and
scalability, or the tools it has access to. Upon a reasoned request of a provider whose model has been designated as
a general-purpose AI model with systemic risk, the Commission should take the request into account and may
decide to reassess whether the general-purpose AI model can still be considered to present systemic risks.
(112)
It is also necessary to clarify a procedure for the classification of a general-purpose AI model with systemic risks.
Show original text
request into account and may
decide to reassess whether the general-purpose AI model can still be considered to present systemic risks.
(112)
It is also necessary to clarify a procedure for the classification of a general-purpose AI model with systemic risks.
A general-purpose AI model that meets the applicable threshold for high-impact capabilities should be presumed to
be a general-purpose AI models with systemic risk. The provider should notify the AI Office at the latest two weeks
after the requirements are met or it becomes known that a general-purpose AI model will meet the requirements
that lead to the presumption. This is especially relevant in relation to the threshold of floating point operations
because training of general-purpose AI models takes considerable planning which includes the upfront allocation of
compute resources and, therefore, providers of general-purpose AI models are able to know if their model would
meet the threshold before the training is completed. In the context of that notification, the provider should be able to
demonstrate that, because of its specific characteristics, a general-purpose AI model exceptionally does not present
systemic risks, and that it thus should not be classified as a general-purpose AI model with systemic risks. That
information is valuable for the AI Office to anticipate the placing on the market of general-purpose AI models with
systemic risks and the providers can start to engage with the AI Office early on. That information is especially
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important with regard to general-purpose AI models that are planned to be released as open-source, given that, after
the open-source model release, necessary measures to ensure compliance with the obligations under this Regulation
may be more difficult to implement.
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It's important to consider
general-purpose AI models that will be released as open-source. Once these models are available, it may be harder to ensure they comply with regulations. If the
Commission discovers that a
general-purpose AI model poses
systemic risks—either because it was previously unknown or not reported by the
provider—it should have the authority to classify it as such. A system of alerts from a
scientific panel will help the
AI Office identify models that may need this classification, in addition to the Office's own monitoring efforts.
Providers of
general-purpose AI models that present
systemic risks will have additional responsibilities. They must identify and reduce these risks and ensure strong
cybersecurity, whether the model is standalone or part of a larger system. To meet these requirements, the
regulation will
mandate that
providers conduct necessary evaluations before the model is first sold, including adversarial testing, which can be done internally or by independent testers. Furthermore, these
providers must continuously assess and manage
systemic risks by implementing risk management policies, ensuring accountability, monitoring the model after it hits the market, and collaborating with others in the
AI value chain.
144
important with regard to general-purpose AI models that are planned to be released as open-source, given that, after
the open-source model release, necessary measures to ensure compliance with the obligations under this Regulation
may be more difficult to implement.
(113)
If the Commission becomes aware of the fact that a general-purpose AI model meets the requirements to classify as
a general-purpose AI model with systemic risk, which previously had either not been known or of which the
relevant provider has failed to notify the Commission, the Commission should be empowered to designate it so.
A system of qualified alerts should ensure that the AI Office is made aware by the scientific panel of general-purpose
AI models that should possibly be classified as general-purpose AI models with systemic risk, in addition to the
monitoring activities of the AI Office.
(114)
The providers of general-purpose AI models presenting systemic risks should be subject, in addition to the
obligations provided for providers of general-purpose AI models, to obligations aimed at identifying and mitigating
those risks and ensuring an adequate level of cybersecurity protection, regardless of whether it is provided as
a standalone model or embedded in an AI system or a product. To achieve those objectives, this Regulation should
require providers to perform the necessary model evaluations, in particular prior to its first placing on the market,
including conducting and documenting adversarial testing of models, also, as appropriate, through internal or
independent external testing. In addition, providers of general-purpose AI models with systemic risks should
continuously assess and mitigate systemic risks, including for example by putting in place risk-management policies,
such as accountability and governance processes, implementing post-market monitoring, taking appropriate
measures along the entire model’s lifecycle and cooperating with relevant actors along the AI value chain.
(115)
Providers of general-purpose AI models with systemic risks should assess and mitigate possible systemic risks.
Show original text
Governance processes should be established for post-market monitoring, taking necessary actions throughout the entire lifecycle of
AI models, and collaborating with key players in the
AI value chain.
Providers of
general-purpose AI models that pose
systemic risks must evaluate and reduce these risks. If a
serious incident occurs despite these efforts, the
provider must promptly document the incident and report relevant details and corrective actions to the
Commission and
national authorities. Additionally,
providers must ensure strong
cybersecurity measures for the model and its infrastructure throughout its lifecycle. This includes protecting against risks from malicious use or attacks, accidental leaks, unauthorized releases, and cyber threats. Security measures should involve safeguarding model weights, algorithms, servers, and datasets through operational security, specific
cybersecurity policies, and access controls tailored to the risks involved. The
AI Office should promote the creation, review, and updating of
codes of practice, considering international standards. All
providers of
general-purpose AI models may be invited to participate. To ensure these codes reflect current best practices and diverse viewpoints, the
AI Office should work with
national authorities and consult with civil society organizations, experts, and the
Scientific Panel. These codes should outline the responsibilities of
providers of
general-purpose AI models, especially those with
systemic risks.
governance processes, implementing post-market monitoring, taking appropriate
measures along the entire model’s lifecycle and cooperating with relevant actors along the AI value chain.
(115)
Providers of general-purpose AI models with systemic risks should assess and mitigate possible systemic risks. If,
despite efforts to identify and prevent risks related to a general-purpose AI model that may present systemic risks,
the development or use of the model causes a serious incident, the general-purpose AI model provider should
without undue delay keep track of the incident and report any relevant information and possible corrective measures
to the Commission and national competent authorities. Furthermore, providers should ensure an adequate level of
cybersecurity protection for the model and its physical infrastructure, if appropriate, along the entire model lifecycle.
Cybersecurity protection related to systemic risks associated with malicious use or attacks should duly consider
accidental model leakage, unauthorised releases, circumvention of safety measures, and defence against cyberattacks,
unauthorised access or model theft. That protection could be facilitated by securing model weights, algorithms,
servers, and data sets, such as through operational security measures for information security, specific cybersecurity
policies, adequate technical and established solutions, and cyber and physical access controls, appropriate to the
relevant circumstances and the risks involved.
(116)
The AI Office should encourage and facilitate the drawing up, review and adaptation of codes of practice, taking into
account international approaches. All providers of general-purpose AI models could be invited to participate. To
ensure that the codes of practice reflect the state of the art and duly take into account a diverse set of perspectives,
the AI Office should collaborate with relevant national competent authorities, and could, where appropriate, consult
with civil society organisations and other relevant stakeholders and experts, including the Scientific Panel, for the
drawing up of such codes. Codes of practice should cover obligations for providers of general-purpose AI models
and of general-purpose AI models presenting systemic risks.
Show original text
Codes of practice will be developed in collaboration with civil society organizations,
stakeholders, and experts, including the
Scientific Panel. These codes will outline the responsibilities of
providers of
general-purpose AI models, especially those that pose
systemic risks. They will help identify and categorize these risks at the
Union level, including their sources, and will focus on specific measures for assessing and reducing these risks.
These codes will be essential for ensuring that
providers of
general-purpose AI models comply with the regulations.
Providers can use these codes to show they are meeting their
obligations. The
Commission may approve a code of practice for general use across the
Union or create common rules if a code cannot be finalized or is found inadequate by the
AI Office when the
regulation takes effect. Once a harmonized standard is published and deemed suitable by the
AI Office, following this standard will imply compliance. Additionally,
providers can demonstrate compliance through other acceptable methods if
codes of practice or harmonized standards are unavailable or if they choose not to use them.
with civil society organisations and other relevant stakeholders and experts, including the Scientific Panel, for the
drawing up of such codes. Codes of practice should cover obligations for providers of general-purpose AI models
and of general-purpose AI models presenting systemic risks. In addition, as regards systemic risks, codes of practice
should help to establish a risk taxonomy of the type and nature of the systemic risks at Union level, including their
sources. Codes of practice should also be focused on specific risk assessment and mitigation measures.
(117)
The codes of practice should represent a central tool for the proper compliance with the obligations provided for
under this Regulation for providers of general-purpose AI models. Providers should be able to rely on codes of
practice to demonstrate compliance with the obligations. By means of implementing acts, the Commission may
decide to approve a code of practice and give it a general validity within the Union, or, alternatively, to provide
common rules for the implementation of the relevant obligations, if, by the time this Regulation becomes applicable,
a code of practice cannot be finalised or is not deemed adequate by the AI Office. Once a harmonised standard is
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published and assessed as suitable to cover the relevant obligations by the AI Office, compliance with a European
harmonised standard should grant providers the presumption of conformity. Providers of general-purpose AI
models should furthermore be able to demonstrate compliance using alternative adequate means, if codes of practice
or harmonised standards are not available, or they choose not to rely on those.
Show original text
The standard should assume that
providers of
general-purpose AI models meet compliance requirements. If there are no available
codes of practice or harmonized standards, these
providers can show compliance through other suitable methods. This
Regulation sets rules for
AI systems and models, requiring market actors to meet specific
obligations when offering them in the EU. This complements the
obligations for
providers of intermediary services that include these
AI systems, as outlined in
Regulation (EU) 2022/2065. If these systems are part of
very large online platforms or search engines, they must follow the risk-management framework in
Regulation (EU) 2022/2065. Therefore, the
obligations in this
Regulation are considered met unless significant
systemic risks arise that are not addressed by
Regulation (EU) 2022/2065.
Providers of
very large online platforms and search engines must evaluate potential
systemic risks related to their services, including risks from the design and use of their algorithms, and take appropriate measures to mitigate these risks while respecting
fundamental rights. Given the rapid innovation and changes in digital services,
AI systems covered by this
Regulation may also be offered as intermediary services, as defined in
Regulation (EU) 2022/2065, and this should be understood in a way that is not limited to specific technologies.
standard should grant providers the presumption of conformity. Providers of general-purpose AI
models should furthermore be able to demonstrate compliance using alternative adequate means, if codes of practice
or harmonised standards are not available, or they choose not to rely on those.
(118)
This Regulation regulates AI systems and AI models by imposing certain requirements and obligations for relevant
market actors that are placing them on the market, putting into service or use in the Union, thereby complementing
obligations for providers of intermediary services that embed such systems or models into their services regulated by
Regulation (EU) 2022/2065. To the extent that such systems or models are embedded into designated very large
online platforms or very large online search engines, they are subject to the risk-management framework provided
for in Regulation (EU) 2022/2065. Consequently, the corresponding obligations of this Regulation should be
presumed to be fulfilled, unless significant systemic risks not covered by Regulation (EU) 2022/2065 emerge and are
identified in such models. Within this framework, providers of very large online platforms and very large online
search engines are obliged to assess potential systemic risks stemming from the design, functioning and use of their
services, including how the design of algorithmic systems used in the service may contribute to such risks, as well as
systemic risks stemming from potential misuses. Those providers are also obliged to take appropriate mitigating
measures in observance of fundamental rights.
(119)
Considering the quick pace of innovation and the technological evolution of digital services in scope of different
instruments of Union law in particular having in mind the usage and the perception of their recipients, the AI
systems subject to this Regulation may be provided as intermediary services or parts thereof within the meaning of
Regulation (EU) 2022/2065, which should be interpreted in a technology-neutral manner.
Show original text
AI systems covered by this
Regulation can act as intermediary services, as defined by
Regulation (EU) 2022/2065, and this should be understood in a way that is not limited to specific technologies. For instance,
AI systems can be used in online search engines. If an
AI system, like an online chatbot, searches through all websites, combines the results with its existing knowledge, and produces a single output, it demonstrates this functionality.
Additionally, the
Regulation imposes
obligations on
providers and
users of certain
AI systems to ensure that it is clear when outputs are artificially generated or altered. This is especially important for
very large online platforms and search engines, which must identify and reduce risks associated with the spread of manipulated content. Such risks can negatively impact democratic processes, public discussions, and elections, particularly through disinformation.
Standardization is crucial for providing
technical solutions that help
providers comply with this
Regulation. It should align with the latest advancements to encourage innovation, competitiveness, and growth in the single market. Adhering to harmonized standards, as outlined in Article 2, point (1)(c) of
Regulation (EU) No 1025/2012, is a way for
providers to show they meet the requirements of this
Regulation.
the perception of their recipients, the AI
systems subject to this Regulation may be provided as intermediary services or parts thereof within the meaning of
Regulation (EU) 2022/2065, which should be interpreted in a technology-neutral manner. For example, AI systems
may be used to provide online search engines, in particular, to the extent that an AI system such as an online chatbot
performs searches of, in principle, all websites, then incorporates the results into its existing knowledge and uses the
updated knowledge to generate a single output that combines different sources of information.
(120)
Furthermore, obligations placed on providers and deployers of certain AI systems in this Regulation to enable the
detection and disclosure that the outputs of those systems are artificially generated or manipulated are particularly
relevant to facilitate the effective implementation of Regulation (EU) 2022/2065. This applies in particular as regards
the obligations of providers of very large online platforms or very large online search engines to identify and
mitigate systemic risks that may arise from the dissemination of content that has been artificially generated or
manipulated, in particular risk of the actual or foreseeable negative effects on democratic processes, civic discourse
and electoral processes, including through disinformation.
(121)
Standardisation should play a key role to provide technical solutions to providers to ensure compliance with this
Regulation, in line with the state of the art, to promote innovation as well as competitiveness and growth in the
single market. Compliance with harmonised standards as defined in Article 2, point (1)(c), of Regulation (EU)
No 1025/2012 of the European Parliament and of the Council (41), which are normally expected to reflect the state
of the art, should be a means for providers to demonstrate conformity with the requirements of this Regulation.
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The
European Parliament and Council Regulation (EU) No 1025/2012 states that standards should reflect the latest advancements and help
providers show they meet regulatory requirements. It is important to include a variety of
stakeholders, especially small and medium-sized enterprises (
SMEs), consumer groups, and environmental and social organizations, in the standard development process as outlined in Articles 5 and 6 of the
regulation. The
European Commission should issue standardization requests promptly to help ensure compliance. When creating these requests, the
Commission should seek advice from an
advisory forum and a
Board to gather necessary expertise. If there are no relevant harmonized standards available, the
Commission can create
common specifications through implementing acts after consulting the
advisory forum. These
common specifications should only be used as a last resort to help
providers meet regulatory requirements when standardization requests are not accepted, when existing standards do not adequately address
fundamental rights, or when there are delays in creating suitable standards due to their technical complexity.
EU)
No 1025/2012 of the European Parliament and of the Council (41), which are normally expected to reflect the state
of the art, should be a means for providers to demonstrate conformity with the requirements of this Regulation.
A balanced representation of interests involving all relevant stakeholders in the development of standards, in
particular SMEs, consumer organisations and environmental and social stakeholders in accordance with Articles 5
and 6 of Regulation (EU) No 1025/2012 should therefore be encouraged. In order to facilitate compliance, the
standardisation requests should be issued by the Commission without undue delay. When preparing the
standardisation request, the Commission should consult the advisory forum and the Board in order to collect
relevant expertise. However, in the absence of relevant references to harmonised standards, the Commission should
be able to establish, via implementing acts, and after consultation of the advisory forum, common specifications for
certain requirements under this Regulation. The common specification should be an exceptional fall back solution to
facilitate the provider’s obligation to comply with the requirements of this Regulation, when the standardisation
request has not been accepted by any of the European standardisation organisations, or when the relevant
harmonised standards insufficiently address fundamental rights concerns, or when the harmonised standards do not
comply with the request, or when there are delays in the adoption of an appropriate harmonised standard. Where
such a delay in the adoption of a harmonised standard is due to the technical complexity of that standard, this should
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or when there are delays in the adoption of an appropriate harmonised standard. Where
such a delay in the adoption of a harmonised standard is due to the technical complexity of that standard, this should
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(41)
Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation,
amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC,
2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council
Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
be considered by the Commission before contemplating the establishment of common specifications. When
developing common specifications, the Commission is encouraged to cooperate with international partners and
international standardisation bodies.
(122)
It is appropriate that, without prejudice to the use of harmonised standards and common specifications, providers of
a high-risk AI system that has been trained and tested on data reflecting the specific geographical, behavioural,
contextual or functional setting within which the AI system is intended to be used, should be presumed to comply
with the relevant measure provided for under the requirement on data governance set out in this Regulation.
Show original text
Data that reflects the specific geographical, behavioral, contextual, or functional setting for which an
AI system is designed is assumed to meet the
data governance requirements outlined in this
Regulation. Additionally,
high-risk AI systems that have been certified or have received a statement of conformity under a
cybersecurity scheme, as per
Article 54(3) of
Regulation (EU) 2019/881, are also presumed to meet the
cybersecurity requirements of this
Regulation, provided that the certification covers those requirements. This does not affect the voluntary nature of the
cybersecurity scheme.
To ensure high trustworthiness in
high-risk AI systems, these systems must undergo a
conformity assessment before they can be marketed or put into service. To reduce the burden on operators and avoid duplication,
high-risk AI systems related to products already covered by existing EU harmonization legislation should be assessed for compliance with this
Regulation as part of the existing
conformity assessment process. The requirements of this
Regulation should not change the established methods or structures of conformity assessments under relevant EU legislation.
Given the complexity and associated risks of
high-risk AI systems, it is crucial to create a suitable
conformity assessment procedure that involves
notified bodies, which are third-party assessors.
on data reflecting the specific geographical, behavioural,
contextual or functional setting within which the AI system is intended to be used, should be presumed to comply
with the relevant measure provided for under the requirement on data governance set out in this Regulation.
Without prejudice to the requirements related to robustness and accuracy set out in this Regulation, in accordance
with Article 54(3) of Regulation (EU) 2019/881, high-risk AI systems that have been certified or for which
a statement of conformity has been issued under a cybersecurity scheme pursuant to that Regulation and the
references of which have been published in the Official Journal of the European Union should be presumed to comply
with the cybersecurity requirement of this Regulation in so far as the cybersecurity certificate or statement of
conformity or parts thereof cover the cybersecurity requirement of this Regulation. This remains without prejudice
to the voluntary nature of that cybersecurity scheme.
(123)
In order to ensure a high level of trustworthiness of high-risk AI systems, those systems should be subject to
a conformity assessment prior to their placing on the market or putting into service.
(124)
It is appropriate that, in order to minimise the burden on operators and avoid any possible duplication, for high-risk
AI systems related to products which are covered by existing Union harmonisation legislation based on the New
Legislative Framework, the compliance of those AI systems with the requirements of this Regulation should be
assessed as part of the conformity assessment already provided for in that law. The applicability of the requirements
of this Regulation should thus not affect the specific logic, methodology or general structure of conformity
assessment under the relevant Union harmonisation legislation.
(125)
Given the complexity of high-risk AI systems and the risks that are associated with them, it is important to develop
an adequate conformity assessment procedure for high-risk AI systems involving notified bodies, so-called third
party conformity assessment.
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Due to the complexity and risks of
high-risk AI systems, it's crucial to create a proper evaluation process for these systems, involving independent third-party assessors. However, initially, this evaluation should mainly be limited to
high-risk AI systems that are not product-related. Generally, the
providers of these
AI systems should assess them themselves, except for those used for
biometrics.
To conduct third-party assessments when necessary,
national authorities must notify independent bodies that meet specific requirements, such as independence, expertise, and
cybersecurity standards. This notification should be sent to the
European Commission and other EU
member states using an electronic tool developed by the
Commission.
In line with EU commitments to the World Trade Organization, it is important to allow mutual recognition of assessment results from qualified bodies, regardless of where they are based, as long as they comply with EU regulations and there is an agreement in place. The
Commission should actively seek international agreements to facilitate this mutual recognition.
legislation.
(125)
Given the complexity of high-risk AI systems and the risks that are associated with them, it is important to develop
an adequate conformity assessment procedure for high-risk AI systems involving notified bodies, so-called third
party conformity assessment. However, given the current experience of professional pre-market certifiers in the field
of product safety and the different nature of risks involved, it is appropriate to limit, at least in an initial phase of
application of this Regulation, the scope of application of third-party conformity assessment for high-risk AI
systems other than those related to products. Therefore, the conformity assessment of such systems should be
carried out as a general rule by the provider under its own responsibility, with the only exception of AI systems
intended to be used for biometrics.
(126)
In order to carry out third-party conformity assessments when so required, notified bodies should be notified under
this Regulation by the national competent authorities, provided that they comply with a set of requirements, in
particular on independence, competence, absence of conflicts of interests and suitable cybersecurity requirements.
Notification of those bodies should be sent by national competent authorities to the Commission and the other
Member States by means of the electronic notification tool developed and managed by the Commission pursuant to
Article R23 of Annex I to Decision No 768/2008/EC.
(127)
In line with Union commitments under the World Trade Organization Agreement on Technical Barriers to Trade, it is
adequate to facilitate the mutual recognition of conformity assessment results produced by competent conformity
assessment bodies, independent of the territory in which they are established, provided that those conformity
assessment bodies established under the law of a third country meet the applicable requirements of this Regulation
and the Union has concluded an agreement to that extent. In this context, the Commission should actively explore
possible international instruments for that purpose and in particular pursue the conclusion of mutual recognition
agreements with third countries.
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the applicable requirements of this Regulation
and the Union has concluded an agreement to that extent. In this context, the Commission should actively explore
possible international instruments for that purpose and in particular pursue the conclusion of mutual recognition
agreements with third countries.
(128)
In line with the commonly established notion of substantial modification for products regulated by Union
harmonisation legislation, it is appropriate that whenever a change occurs which may affect the compliance of
a high-risk AI system with this Regulation (e.g. change of operating system or software architecture), or when the
intended purpose of the system changes, that AI system should be considered to be a new AI system which should
undergo a new conformity assessment. However, changes occurring to the algorithm and the performance of AI
systems which continue to ‘learn’ after being placed on the market or put into service, namely automatically
adapting how functions are carried out, should not constitute a substantial modification, provided that those
changes have been pre-determined by the provider and assessed at the moment of the conformity assessment.
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(129)
High-risk AI systems should bear the CE marking to indicate their conformity with this Regulation so that they can
move freely within the internal market. For high-risk AI systems embedded in a product, a physical CE marking
should be affixed, and may be complemented by a digital CE marking. For high-risk AI systems only provided
digitally, a digital CE marking should be used. Member States should not create unjustified obstacles to the placing
on the market or the putting into service of high-risk AI systems that comply with the requirements laid down in
this Regulation and bear the CE marking.
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A
digital CE marking must be used for
high-risk AI systems.
Member States should not create unnecessary barriers to the market entry or use of these systems if they meet the requirements of this
Regulation and have the
CE marking. In certain situations, quick access to innovative technologies is essential for public health, safety, environmental protection, and societal well-being. Therefore, in exceptional cases related to
public security or the protection of life and health,
market surveillance authorities may allow the use of
AI systems that haven't completed a
conformity assessment. In justified cases,
law enforcement or civil protection authorities can also use a specific
high-risk AI system without prior approval from market surveillance, as long as they request authorization promptly after starting its use. To help the
Commission and
Member States in managing
AI and to improve public
transparency,
providers of
high-risk AI systems (not covered by existing EU regulations) must register themselves and their
AI systems in a new
EU database managed by the
Commission. Before using any
AI system classified as high-risk,
public authorities, agencies, or bodies must also register in this database and indicate which system they plan to use.
a digital CE marking should be used. Member States should not create unjustified obstacles to the placing
on the market or the putting into service of high-risk AI systems that comply with the requirements laid down in
this Regulation and bear the CE marking.
(130)
Under certain conditions, rapid availability of innovative technologies may be crucial for health and safety of
persons, the protection of the environment and climate change and for society as a whole. It is thus appropriate that
under exceptional reasons of public security or protection of life and health of natural persons, environmental
protection and the protection of key industrial and infrastructural assets, market surveillance authorities could
authorise the placing on the market or the putting into service of AI systems which have not undergone
a conformity assessment. In duly justified situations, as provided for in this Regulation, law enforcement authorities
or civil protection authorities may put a specific high-risk AI system into service without the authorisation of the
market surveillance authority, provided that such authorisation is requested during or after the use without undue
delay.
(131)
In order to facilitate the work of the Commission and the Member States in the AI field as well as to increase the
transparency towards the public, providers of high-risk AI systems other than those related to products falling within
the scope of relevant existing Union harmonisation legislation, as well as providers who consider that an AI system
listed in the high-risk use cases in an annex to this Regulation is not high-risk on the basis of a derogation, should be
required to register themselves and information about their AI system in an EU database, to be established and
managed by the Commission. Before using an AI system listed in the high-risk use cases in an annex to this
Regulation, deployers of high-risk AI systems that are public authorities, agencies or bodies, should register
themselves in such database and select the system that they envisage to use.
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Public authorities, agencies, or bodies that use
high-risk AI systems must register in the
EU database and specify the systems they plan to use. Other
users can register voluntarily. This section of the database will be publicly accessible and free to use, with information that is easy to navigate, understand, and read by machines. The database should be user-friendly, allowing searches by keywords so that the public can find relevant information about registered
high-risk AI systems and their use cases. Any significant changes to these systems must also be recorded in the database. For
high-risk AI systems related to
law enforcement,
migration,
asylum, and border control, registration must occur in a secure, non-public section of the database, accessible only to the
European Commission and national
market surveillance authorities.
High-risk AI systems related to
critical infrastructure should only be registered at the national level. The
European Commission will manage the
EU database according to
Regulation (EU) 2018/1725. To ensure the database works properly, the
Commission will develop functional specifications and conduct an independent audit. The
Commission will also consider
cybersecurity risks while managing the database.
the high-risk use cases in an annex to this
Regulation, deployers of high-risk AI systems that are public authorities, agencies or bodies, should register
themselves in such database and select the system that they envisage to use. Other deployers should be entitled to do
so voluntarily. This section of the EU database should be publicly accessible, free of charge, the information should
be easily navigable, understandable and machine-readable. The EU database should also be user-friendly, for example
by providing search functionalities, including through keywords, allowing the general public to find relevant
information to be submitted upon the registration of high-risk AI systems and on the use case of high-risk AI
systems, set out in an annex to this Regulation, to which the high-risk AI systems correspond. Any substantial
modification of high-risk AI systems should also be registered in the EU database. For high-risk AI systems in the
area of law enforcement, migration, asylum and border control management, the registration obligations should be
fulfilled in a secure non-public section of the EU database. Access to the secure non-public section should be strictly
limited to the Commission as well as to market surveillance authorities with regard to their national section of that
database. High-risk AI systems in the area of critical infrastructure should only be registered at national level. The
Commission should be the controller of the EU database, in accordance with Regulation (EU) 2018/1725. In order
to ensure the full functionality of the EU database, when deployed, the procedure for setting the database should
include the development of functional specifications by the Commission and an independent audit report. The
Commission should take into account cybersecurity risks when carrying out its tasks as data controller on the EU
database.
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When the database is set up, the process should include creating functional specifications by the
Commission and an independent
audit report. The
Commission must consider
cybersecurity risks while acting as the
data controller for the
EU database. To ensure the public can easily access and use the
EU database, it must meet the requirements of
Directive (EU) 2019/882.
Certain
AI systems that interact with people or create content may carry risks of impersonation or deception, regardless of whether they are classified as high-risk. Therefore, these systems should have specific
transparency requirements, while still adhering to the rules for
high-risk AI systems, with some exceptions for
law enforcement needs.
Specifically, people should be informed when they are interacting with an
AI system, unless it is clear to a reasonably informed and observant person based on the situation. When enforcing this requirement, the needs of
vulnerable groups, such as the elderly or disabled, should be considered, especially if the
AI system is designed to interact with them. Additionally, individuals should be notified if
AI systems process their
biometric data to identify or infer their emotions or intentions, or to categorize them based on traits like sex, age, hair color, eye color, tattoos, ethnic origin, and personal interests. This information should be provided in accessible formats for people with disabilities.
, when deployed, the procedure for setting the database should
include the development of functional specifications by the Commission and an independent audit report. The
Commission should take into account cybersecurity risks when carrying out its tasks as data controller on the EU
database. In order to maximise the availability and use of the EU database by the public, the EU database, including
the information made available through it, should comply with requirements under the Directive (EU) 2019/882.
(132)
Certain AI systems intended to interact with natural persons or to generate content may pose specific risks of
impersonation or deception irrespective of whether they qualify as high-risk or not. In certain circumstances, the use
of these systems should therefore be subject to specific transparency obligations without prejudice to the
requirements and obligations for high-risk AI systems and subject to targeted exceptions to take into account the
special need of law enforcement. In particular, natural persons should be notified that they are interacting with an AI
system, unless this is obvious from the point of view of a natural person who is reasonably well-informed, observant
and circumspect taking into account the circumstances and the context of use. When implementing that obligation,
the characteristics of natural persons belonging to vulnerable groups due to their age or disability should be taken
into account to the extent the AI system is intended to interact with those groups as well. Moreover, natural persons
should be notified when they are exposed to AI systems that, by processing their biometric data, can identify or infer
the emotions or intentions of those persons or assign them to specific categories. Such specific categories can relate
to aspects such as sex, age, hair colour, eye colour, tattoos, personal traits, ethnic origin, personal preferences and
interests. Such information and notifications should be provided in accessible formats for persons with disabilities.
OJ L, 12.7.
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Information such as sex, age, hair color, eye color, tattoos, personal traits, ethnic origin, preferences, and interests should be provided in formats that are accessible to people with disabilities.
A variety of
AI systems can create large amounts of
synthetic content that is becoming harder for people to tell apart from real, human-generated content. The widespread use and growing capabilities of these systems pose risks to the integrity and trustworthiness of information, leading to issues like misinformation, manipulation, fraud, impersonation, and consumer deception.
To address these challenges, it is important for
providers of
AI systems to include
technical solutions that can mark content in a machine-readable way, indicating whether it was generated or altered by
AI rather than a human. These solutions should be reliable, compatible, effective, and robust, considering the available technologies. Possible methods include
watermarks, metadata identification, cryptographic techniques to verify the origin and authenticity of content,
logging methods, and
fingerprints.
When implementing these requirements,
providers should consider the unique characteristics and limitations of different types of content, as well as current technological and market trends. These techniques can be applied at the level of the
AI system or the
AI model, including
general-purpose AI models that generate content, making it easier for downstream
providers to comply with these
obligations.
as sex, age, hair colour, eye colour, tattoos, personal traits, ethnic origin, personal preferences and
interests. Such information and notifications should be provided in accessible formats for persons with disabilities.
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(133)
A variety of AI systems can generate large quantities of synthetic content that becomes increasingly hard for humans
to distinguish from human-generated and authentic content. The wide availability and increasing capabilities of
those systems have a significant impact on the integrity and trust in the information ecosystem, raising new risks of
misinformation and manipulation at scale, fraud, impersonation and consumer deception. In light of those impacts,
the fast technological pace and the need for new methods and techniques to trace origin of information, it is
appropriate to require providers of those systems to embed technical solutions that enable marking in a machine
readable format and detection that the output has been generated or manipulated by an AI system and not a human.
Such techniques and methods should be sufficiently reliable, interoperable, effective and robust as far as this is
technically feasible, taking into account available techniques or a combination of such techniques, such as
watermarks, metadata identifications, cryptographic methods for proving provenance and authenticity of content,
logging methods, fingerprints or other techniques, as may be appropriate. When implementing this obligation,
providers should also take into account the specificities and the limitations of the different types of content and the
relevant technological and market developments in the field, as reflected in the generally acknowledged state of the
art. Such techniques and methods can be implemented at the level of the AI system or at the level of the AI model,
including general-purpose AI models generating content, thereby facilitating fulfilment of this obligation by the
downstream provider of the AI system.
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Techniques and methods can be applied either at the
AI system level or the
AI model level, including
general-purpose AI models that create content. This helps the
provider of the
AI system meet their
obligations. However, this marking requirement should not apply to
AI systems that mainly assist with standard editing or those that do not significantly change the input
data provided by the user. Additionally, if a
deployer uses an
AI system to create or alter images, audio, or video that closely resembles real people, objects, places, or events (known as
deep fakes), they must clearly label the content to show it has been artificially created or manipulated. This
transparency requirement does not limit the right to freedom of expression or the arts, especially when the content is clearly creative, satirical, artistic, fictional, or similar. In such cases, the obligation to disclose
deep fakes is limited to informing viewers that the content is generated or manipulated, without interfering with the enjoyment or use of the work.
Such techniques and methods can be implemented at the level of the AI system or at the level of the AI model,
including general-purpose AI models generating content, thereby facilitating fulfilment of this obligation by the
downstream provider of the AI system. To remain proportionate, it is appropriate to envisage that this marking
obligation should not cover AI systems performing primarily an assistive function for standard editing or AI systems
not substantially altering the input data provided by the deployer or the semantics thereof.
(134)
Further to the technical solutions employed by the providers of the AI system, deployers who use an AI system to
generate or manipulate image, audio or video content that appreciably resembles existing persons, objects, places,
entities or events and would falsely appear to a person to be authentic or truthful (deep fakes), should also clearly
and distinguishably disclose that the content has been artificially created or manipulated by labelling the AI output
accordingly and disclosing its artificial origin. Compliance with this transparency obligation should not be
interpreted as indicating that the use of the AI system or its output impedes the right to freedom of expression and
the right to freedom of the arts and sciences guaranteed in the Charter, in particular where the content is part of an
evidently creative, satirical, artistic, fictional or analogous work or programme, subject to appropriate safeguards for
the rights and freedoms of third parties. In those cases, the transparency obligation for deep fakes set out in this
Regulation is limited to disclosure of the existence of such generated or manipulated content in an appropriate
manner that does not hamper the display or enjoyment of the work, including its normal exploitation and use, while
maintaining the utility and quality of the work.
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Content that is generated or manipulated by
AI must be disclosed in a way that does not interfere with how the work is displayed or enjoyed. This includes ensuring the work can still be used effectively and maintains its quality. Additionally, if
AI-generated or manipulated text is published to inform the public about important issues, it should also be disclosed unless it has been reviewed by a human or has editorial oversight from a responsible person or organization.
The
Commission may promote the creation of
codes of practice at the EU level to help implement these
transparency obligations. This includes making detection and labeling of
AI-generated content easier and encouraging cooperation among different
stakeholders to ensure the public can recognize such content.
Providers and
users of certain
AI systems must comply with regulations that require them to disclose when their outputs are artificially generated or manipulated. This is especially important for large online platforms and search engines, which need to identify and reduce risks associated with the spread of
AI-generated content, particularly concerning its potential negative impact on democracy, public discussion, and elections, including the spread of misinformation.
limited to disclosure of the existence of such generated or manipulated content in an appropriate
manner that does not hamper the display or enjoyment of the work, including its normal exploitation and use, while
maintaining the utility and quality of the work. In addition, it is also appropriate to envisage a similar disclosure
obligation in relation to AI-generated or manipulated text to the extent it is published with the purpose of informing
the public on matters of public interest unless the AI-generated content has undergone a process of human review or
editorial control and a natural or legal person holds editorial responsibility for the publication of the content.
(135)
Without prejudice to the mandatory nature and full applicability of the transparency obligations, the Commission
may also encourage and facilitate the drawing up of codes of practice at Union level to facilitate the effective
implementation of the obligations regarding the detection and labelling of artificially generated or manipulated
content, including to support practical arrangements for making, as appropriate, the detection mechanisms
accessible and facilitating cooperation with other actors along the value chain, disseminating content or checking its
authenticity and provenance to enable the public to effectively distinguish AI-generated content.
(136)
The obligations placed on providers and deployers of certain AI systems in this Regulation to enable the detection
and disclosure that the outputs of those systems are artificially generated or manipulated are particularly relevant to
facilitate the effective implementation of Regulation (EU) 2022/2065. This applies in particular as regards the
obligations of providers of very large online platforms or very large online search engines to identify and mitigate
systemic risks that may arise from the dissemination of content that has been artificially generated or manipulated,
in particular the risk of the actual or foreseeable negative effects on democratic processes, civic discourse and
electoral processes, including through disinformation.
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The goal is to reduce
systemic risks that can come from sharing content that is created or altered by artificial intelligence (
AI). This includes risks that could negatively impact democracy, public discussions, and elections, especially through misinformation. The requirement to label
AI-generated content does not affect the
obligations of hosting service
providers under
Article 16(6) of
Regulation (EU) 2022/2065 to handle notices about illegal content as outlined in
Article 16(1). The legality of specific content should be judged based solely on existing laws regarding content legality.
Compliance with
transparency requirements for
AI systems under this
Regulation does not imply that using the
AI system or its results is legal under this
Regulation or any other EU or national laws. It also does not affect other
transparency obligations for
AI system developers set by EU or national laws.
AI technology is evolving quickly and needs regulatory oversight and a safe environment for testing. This ensures responsible innovation and the implementation of necessary
safeguards. To create a legal framework that encourages innovation and can adapt to changes,
Member States should ensure that their
national authorities establish at least one
AI regulatory sandbox. This
sandbox will allow for the development and testing of new
AI systems under strict regulatory supervision before they are released to the market or used.
mitigate
systemic risks that may arise from the dissemination of content that has been artificially generated or manipulated,
in particular the risk of the actual or foreseeable negative effects on democratic processes, civic discourse and
electoral processes, including through disinformation. The requirement to label content generated by AI systems
under this Regulation is without prejudice to the obligation in Article 16(6) of Regulation (EU) 2022/2065 for
providers of hosting services to process notices on illegal content received pursuant to Article 16(1) of that
Regulation and should not influence the assessment and the decision on the illegality of the specific content. That
assessment should be performed solely with reference to the rules governing the legality of the content.
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(137)
Compliance with the transparency obligations for the AI systems covered by this Regulation should not be
interpreted as indicating that the use of the AI system or its output is lawful under this Regulation or other Union
and Member State law and should be without prejudice to other transparency obligations for deployers of AI systems
laid down in Union or national law.
(138)
AI is a rapidly developing family of technologies that requires regulatory oversight and a safe and controlled space
for experimentation, while ensuring responsible innovation and integration of appropriate safeguards and risk
mitigation measures. To ensure a legal framework that promotes innovation, is future-proof and resilient to
disruption, Member States should ensure that their national competent authorities establish at least one AI
regulatory sandbox at national level to facilitate the development and testing of innovative AI systems under strict
regulatory oversight before these systems are placed on the market or otherwise put into service.
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Countries should make sure that their
national authorities create at least one
AI regulatory sandbox to help develop and test new
AI systems under strict rules before these systems are sold or used.
Member States can meet this requirement by joining existing sandboxes or by creating a joint
sandbox with other
Member States, as long as it provides similar coverage for all involved.
AI regulatory sandboxes can be physical, digital, or a mix of both, and they should support both physical and digital products. The authorities setting up these sandboxes must ensure they have enough financial and human resources to operate effectively.
The main goals of the
AI regulatory sandboxes are to promote
AI innovation by providing a controlled environment for testing during the development phase, ensuring that new
AI systems comply with regulations and laws. Additionally, these sandboxes should help clarify legal issues for innovators and improve the understanding of
AI's risks and impacts for authorities. This will aid in regulatory learning, support cooperation among involved authorities, and help remove barriers for small and medium-sized enterprises (
SMEs) and
start-ups to access markets.
AI regulatory sandboxes should be accessible across the
Union, with a focus on making them available for
SMEs and
start-ups. Participation in these sandboxes should address legal uncertainties that hinder innovation and experimentation with
AI in the
Union.
States should ensure that their national competent authorities establish at least one AI
regulatory sandbox at national level to facilitate the development and testing of innovative AI systems under strict
regulatory oversight before these systems are placed on the market or otherwise put into service. Member States
could also fulfil this obligation through participating in already existing regulatory sandboxes or establishing jointly
a sandbox with one or more Member States’ competent authorities, insofar as this participation provides equivalent
level of national coverage for the participating Member States. AI regulatory sandboxes could be established in
physical, digital or hybrid form and may accommodate physical as well as digital products. Establishing authorities
should also ensure that the AI regulatory sandboxes have the adequate resources for their functioning, including
financial and human resources.
(139)
The objectives of the AI regulatory sandboxes should be to foster AI innovation by establishing a controlled
experimentation and testing environment in the development and pre-marketing phase with a view to ensuring
compliance of the innovative AI systems with this Regulation and other relevant Union and national law. Moreover,
the AI regulatory sandboxes should aim to enhance legal certainty for innovators and the competent authorities’
oversight and understanding of the opportunities, emerging risks and the impacts of AI use, to facilitate regulatory
learning for authorities and undertakings, including with a view to future adaptions of the legal framework, to
support cooperation and the sharing of best practices with the authorities involved in the AI regulatory sandbox,
and to accelerate access to markets, including by removing barriers for SMEs, including start-ups. AI regulatory
sandboxes should be widely available throughout the Union, and particular attention should be given to their
accessibility for SMEs, including start-ups. The participation in the AI regulatory sandbox should focus on issues that
raise legal uncertainty for providers and prospective providers to innovate, experiment with AI in the Union and
contribute to evidence-based regulatory learning.
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The
AI regulatory sandbox aims to improve accessibility for small and medium-sized enterprises (
SMEs), including
start-ups. Its focus is on addressing legal uncertainties that may hinder innovation and experimentation with
AI in the
European Union. The supervision of
AI systems within this
sandbox will include their development, training, testing, and validation before they are launched or used. Any significant changes to these systems may require a new assessment to ensure compliance. If major risks are found during development and testing, they must be addressed, or the development process may be halted.
National authorities responsible for
AI regulatory sandboxes should collaborate with other relevant organizations, such as those overseeing
fundamental rights, and may involve various
stakeholders in the
AI ecosystem, including standardization bodies, testing facilities, research labs, and civil society organizations. To ensure consistent implementation across the EU and to achieve economies of scale, common rules for the operation of these sandboxes should be established, along with a framework for cooperation among the supervising authorities. The
AI regulatory sandboxes created under this
regulation do not interfere with other laws that allow for the creation of different sandboxes aimed at ensuring legal compliance. When appropriate, authorities managing these other sandboxes should consider using them to ensure
AI systems comply with this
regulation. With mutual agreement, real-world testing may also take place within the
AI regulatory sandbox.
accessibility for SMEs, including start-ups. The participation in the AI regulatory sandbox should focus on issues that
raise legal uncertainty for providers and prospective providers to innovate, experiment with AI in the Union and
contribute to evidence-based regulatory learning. The supervision of the AI systems in the AI regulatory sandbox
should therefore cover their development, training, testing and validation before the systems are placed on the
market or put into service, as well as the notion and occurrence of substantial modification that may require a new
conformity assessment procedure. Any significant risks identified during the development and testing of such AI
systems should result in adequate mitigation and, failing that, in the suspension of the development and testing
process. Where appropriate, national competent authorities establishing AI regulatory sandboxes should cooperate
with other relevant authorities, including those supervising the protection of fundamental rights, and could allow for
the involvement of other actors within the AI ecosystem such as national or European standardisation organisations,
notified bodies, testing and experimentation facilities, research and experimentation labs, European Digital
Innovation Hubs and relevant stakeholder and civil society organisations. To ensure uniform implementation across
the Union and economies of scale, it is appropriate to establish common rules for the AI regulatory sandboxes’
implementation and a framework for cooperation between the relevant authorities involved in the supervision of the
sandboxes. AI regulatory sandboxes established under this Regulation should be without prejudice to other law
allowing for the establishment of other sandboxes aiming to ensure compliance with law other than this Regulation.
Where appropriate, relevant competent authorities in charge of those other regulatory sandboxes should consider
the benefits of using those sandboxes also for the purpose of ensuring compliance of AI systems with this
Regulation. Upon agreement between the national competent authorities and the participants in the AI regulatory
sandbox, testing in real world conditions may also be operated and supervised in the framework of the AI regulatory
sandbox.
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This
Regulation aims to ensure that
AI systems comply with legal standards. If agreed upon by
national authorities and participants in the
AI regulatory sandbox, real-world testing can be conducted and monitored within this framework.
The
Regulation allows
AI providers to use
personal data collected for other purposes to develop certain
AI systems that serve the
public interest, but only under specific conditions outlined in existing EU regulations. All other
obligations for
data controllers and rights for
data subjects under these regulations still apply. Notably, this
Regulation does not provide a legal basis for certain automated decisions as specified in previous EU regulations.
AI providers in the regulatory
sandbox must implement appropriate
safeguards and work closely with authorities. They should follow guidance and act quickly and in good faith to address any significant risks to safety, health, and
fundamental rights that may arise during development, testing, and experimentation.
of ensuring compliance of AI systems with this
Regulation. Upon agreement between the national competent authorities and the participants in the AI regulatory
sandbox, testing in real world conditions may also be operated and supervised in the framework of the AI regulatory
sandbox.
(140)
This Regulation should provide the legal basis for the providers and prospective providers in the AI regulatory
sandbox to use personal data collected for other purposes for developing certain AI systems in the public interest
within the AI regulatory sandbox, only under specified conditions, in accordance with Article 6(4) and Article 9(2),
point (g), of Regulation (EU) 2016/679, and Articles 5, 6 and 10 of Regulation (EU) 2018/1725, and without
prejudice to Article 4(2) and Article 10 of Directive (EU) 2016/680. All other obligations of data controllers and
rights of data subjects under Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680 remain
applicable. In particular, this Regulation should not provide a legal basis in the meaning of Article 22(2), point (b) of
Regulation (EU) 2016/679 and Article 24(2), point (b) of Regulation (EU) 2018/1725. Providers and prospective
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providers in the AI regulatory sandbox should ensure appropriate safeguards and cooperate with the competent
authorities, including by following their guidance and acting expeditiously and in good faith to adequately mitigate
any identified significant risks to safety, health, and fundamental rights that may arise during the development,
testing and experimentation in that sandbox.
Show original text
Competent authorities must provide guidance and act quickly and in good faith to address any significant risks to safety, health, and
fundamental rights that may arise during the development, testing, and experimentation of
high-risk AI systems in a regulatory
sandbox. To speed up the development and market introduction of these
high-risk AI systems,
providers can also test their systems in real-world conditions without being part of an
AI regulatory sandbox. However, this testing must include proper
safeguards to protect individuals. These
safeguards include obtaining
informed consent from participants, except in
law enforcement situations where consent could hinder testing. It's important to note that consent for testing is separate from consent for processing
personal data under
data protection laws. To minimize risks and ensure oversight, prospective
providers must submit a
real-world testing plan to the relevant
market surveillance authority, register their testing in specific sections of the
EU database (with some exceptions), limit the duration of testing, provide additional protections for
vulnerable groups, and establish a written agreement outlining the roles and responsibilities of all parties involved in the testing.
competent
authorities, including by following their guidance and acting expeditiously and in good faith to adequately mitigate
any identified significant risks to safety, health, and fundamental rights that may arise during the development,
testing and experimentation in that sandbox.
(141)
In order to accelerate the process of development and the placing on the market of the high-risk AI systems listed in
an annex to this Regulation, it is important that providers or prospective providers of such systems may also benefit
from a specific regime for testing those systems in real world conditions, without participating in an AI regulatory
sandbox. However, in such cases, taking into account the possible consequences of such testing on individuals, it
should be ensured that appropriate and sufficient guarantees and conditions are introduced by this Regulation for
providers or prospective providers. Such guarantees should include, inter alia, requesting informed consent of
natural persons to participate in testing in real world conditions, with the exception of law enforcement where the
seeking of informed consent would prevent the AI system from being tested. Consent of subjects to participate in
such testing under this Regulation is distinct from, and without prejudice to, consent of data subjects for the
processing of their personal data under the relevant data protection law. It is also important to minimise the risks
and enable oversight by competent authorities and therefore require prospective providers to have a real-world
testing plan submitted to competent market surveillance authority, register the testing in dedicated sections in the EU
database subject to some limited exceptions, set limitations on the period for which the testing can be done and
require additional safeguards for persons belonging to certain vulnerable groups, as well as a written agreement
defining the roles and responsibilities of prospective providers and deployers and effective oversight by competent
personnel involved in the real world testing.
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Additional
safeguards are needed for
vulnerable groups during real-world testing of
AI systems. This includes a written agreement that outlines the roles and responsibilities of those involved, as well as effective oversight by qualified personnel. It's important to ensure that any predictions or decisions made by the
AI can be reversed and that
personal data is protected. If participants withdraw their consent, their
data must be deleted, in line with
Union data protection laws.
Data collected for testing should only be transferred to other countries if proper
safeguards are in place, especially for
personal data, following
Union data protection regulations. To promote positive social and environmental outcomes from
AI,
Member States should support research and development of
AI solutions that enhance accessibility for people with disabilities, address socio-economic inequalities, and help meet environmental goals. This support should include adequate funding and focus on projects that meet these objectives, encouraging collaboration among
AI developers, experts in inequality and non-
discrimination, and academics.
can be done and
require additional safeguards for persons belonging to certain vulnerable groups, as well as a written agreement
defining the roles and responsibilities of prospective providers and deployers and effective oversight by competent
personnel involved in the real world testing. Furthermore, it is appropriate to envisage additional safeguards to
ensure that the predictions, recommendations or decisions of the AI system can be effectively reversed and
disregarded and that personal data is protected and is deleted when the subjects have withdrawn their consent to
participate in the testing without prejudice to their rights as data subjects under the Union data protection law. As
regards transfer of data, it is also appropriate to envisage that data collected and processed for the purpose of testing
in real-world conditions should be transferred to third countries only where appropriate and applicable safeguards
under Union law are implemented, in particular in accordance with bases for transfer of personal data under Union
law on data protection, while for non-personal data appropriate safeguards are put in place in accordance with
Union law, such as Regulations (EU) 2022/868 (42) and (EU) 2023/2854 (43) of the European Parliament and of the
Council.
(142)
To ensure that AI leads to socially and environmentally beneficial outcomes, Member States are encouraged to
support and promote research and development of AI solutions in support of socially and environmentally
beneficial outcomes, such as AI-based solutions to increase accessibility for persons with disabilities, tackle
socio-economic inequalities, or meet environmental targets, by allocating sufficient resources, including public and
Union funding, and, where appropriate and provided that the eligibility and selection criteria are fulfilled,
considering in particular projects which pursue such objectives. Such projects should be based on the principle of
interdisciplinary cooperation between AI developers, experts on inequality and non-discrimination, accessibility,
consumer, environmental, and digital rights, as well as academics.
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Projects aimed at addressing inequality and
discrimination should involve collaboration among
AI developers, experts in inequality, accessibility, consumer rights, environmental rights, digital rights, and academics. To support innovation, it's crucial to consider the needs of small and medium-sized enterprises (
SMEs) and
start-ups that provide or use
AI systems.
Member States should create initiatives to raise awareness and share information with these businesses.
SMEs and
start-ups with a registered office or branch in the EU should have priority access to
AI regulatory sandboxes, as long as they meet the eligibility criteria. Other
providers can also access these sandboxes if they meet the same conditions.
Member States should establish effective communication channels to support
SMEs and
start-ups, helping them understand and implement regulations. These channels should collaborate to ensure consistent guidance. Additionally,
Member States should encourage SME participation in standardization processes and address their specific needs.
ing in particular projects which pursue such objectives. Such projects should be based on the principle of
interdisciplinary cooperation between AI developers, experts on inequality and non-discrimination, accessibility,
consumer, environmental, and digital rights, as well as academics.
(143)
In order to promote and protect innovation, it is important that the interests of SMEs, including start-ups, that are
providers or deployers of AI systems are taken into particular account. To that end, Member States should develop
initiatives, which are targeted at those operators, including on awareness raising and information communication.
Member States should provide SMEs, including start-ups, that have a registered office or a branch in the Union, with
priority access to the AI regulatory sandboxes provided that they fulfil the eligibility conditions and selection criteria
and without precluding other providers and prospective providers to access the sandboxes provided the same
conditions and criteria are fulfilled. Member States should utilise existing channels and where appropriate, establish
new dedicated channels for communication with SMEs, including start-ups, deployers, other innovators and, as
appropriate, local public authorities, to support SMEs throughout their development path by providing guidance
and responding to queries about the implementation of this Regulation. Where appropriate, these channels should
work together to create synergies and ensure homogeneity in their guidance to SMEs, including start-ups, and
deployers. Additionally, Member States should facilitate the participation of SMEs and other relevant stakeholders in
the standardisation development processes. Moreover, the specific interests and needs of providers that are SMEs,
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Member States should help small and medium-sized enterprises (
SMEs) and other important groups take part in the development of standards. They need to consider the specific needs of
SMEs, including
start-ups, when setting fees for conformity assessments. The
European Commission should regularly evaluate the costs of certification and compliance for
SMEs and work with
Member States to reduce these costs. For instance, translation costs for required documents and communication with authorities can be a major expense for smaller
providers.
Member States should ensure that one of the accepted languages for documentation and communication is widely understood by as many cross-border operators as possible.
. Additionally, Member States should facilitate the participation of SMEs and other relevant stakeholders in
the standardisation development processes. Moreover, the specific interests and needs of providers that are SMEs,
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(42)
Regulation (EU) 2022/868 of the European Parliament and of the Council of 30 May 2022 on European data governance and
amending Regulation (EU) 2018/1724 (Data Governance Act) (OJ L 152, 3.6.2022, p. 1).
(43)
Regulation (EU) 2023/2854 of the European Parliament and of the Council of 13 December 2023 on harmonised rules on fair
access to and use of data and amending Regulation (EU) 2017/2394 and Directive (EU) 2020/1828 (Data Act) (OJ L, 2023/2854,
22.12.2023, ELI: http://data.europa.eu/eli/reg/2023/2854/oj).
including start-ups, should be taken into account when notified bodies set conformity assessment fees. The
Commission should regularly assess the certification and compliance costs for SMEs, including start-ups, through
transparent consultations and should work with Member States to lower such costs. For example, translation costs
related to mandatory documentation and communication with authorities may constitute a significant cost for
providers and other operators, in particular those of a smaller scale. Member States should possibly ensure that one
of the languages determined and accepted by them for relevant providers’ documentation and for communication
with operators is one which is broadly understood by the largest possible number of cross-border deployers.
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Member States should ensure that one of the languages they choose for important documents and communication with operators is widely understood by as many cross-border deployers as possible. To help small and medium-sized enterprises (
SMEs), including
start-ups, the
Commission should provide standardized templates related to this
Regulation when requested by the
Board. Additionally, the
Commission should support
Member States by creating a single, user-friendly information platform about this
Regulation for all
providers and deployers. They should also run communication campaigns to raise awareness of the
obligations under this
Regulation and promote best practices in public procurement for
AI systems. Medium-sized enterprises that were previously classified as small under the
Commission Recommendation 2003/361/EC should also have access to these support measures, as they may lack the legal resources and training needed to understand and comply with this
Regulation. To foster innovation, the
AI-on-demand platform and relevant EU funding programs, like the
Digital Europe Programme and
Horizon Europe, should help achieve the goals of this
Regulation. To reduce risks from a lack of knowledge in the market and to help
providers, especially
SMEs and
start-ups, comply with their
obligations, the
AI-on-demand platform,
European Digital Innovation Hubs, and testing facilities set up by the
Commission and
Member States should assist in implementing this
Regulation.
those of a smaller scale. Member States should possibly ensure that one
of the languages determined and accepted by them for relevant providers’ documentation and for communication
with operators is one which is broadly understood by the largest possible number of cross-border deployers. In order
to address the specific needs of SMEs, including start-ups, the Commission should provide standardised templates for
the areas covered by this Regulation, upon request of the Board. Additionally, the Commission should complement
Member States’ efforts by providing a single information platform with easy-to-use information with regards to this
Regulation for all providers and deployers, by organising appropriate communication campaigns to raise awareness
about the obligations arising from this Regulation, and by evaluating and promoting the convergence of best
practices in public procurement procedures in relation to AI systems. Medium-sized enterprises which until recently
qualified as small enterprises within the meaning of the Annex to Commission Recommendation 2003/361/EC (44)
should have access to those support measures, as those new medium-sized enterprises may sometimes lack the legal
resources and training necessary to ensure proper understanding of, and compliance with, this Regulation.
(144)
In order to promote and protect innovation, the AI-on-demand platform, all relevant Union funding programmes
and projects, such as Digital Europe Programme, Horizon Europe, implemented by the Commission and the Member
States at Union or national level should, as appropriate, contribute to the achievement of the objectives of this
Regulation.
(145)
In order to minimise the risks to implementation resulting from lack of knowledge and expertise in the market as
well as to facilitate compliance of providers, in particular SMEs, including start-ups, and notified bodies with their
obligations under this Regulation, the AI-on-demand platform, the European Digital Innovation Hubs and the
testing and experimentation facilities established by the Commission and the Member States at Union or national
level should contribute to the implementation of this Regulation.
Show original text
obligations under this Regulation, the AI-on-demand platform, the European Digital Innovation Hubs and the
testing and experimentation facilities established by the Commission and the Member States at Union or national
level should contribute to the implementation of this Regulation. Within their respective mission and fields of
competence, the AI-on-demand platform, the European Digital Innovation Hubs and the testing and
experimentation Facilities are able to provide in particular technical and scientific support to providers and
notified bodies.
(146)
Moreover, in light of the very small size of some operators and in order to ensure proportionality regarding costs of
innovation, it is appropriate to allow microenterprises to fulfil one of the most costly obligations, namely to
establish a quality management system, in a simplified manner which would reduce the administrative burden and
the costs for those enterprises without affecting the level of protection and the need for compliance with the
requirements for high-risk AI systems. The Commission should develop guidelines to specify the elements of the
quality management system to be fulfilled in this simplified manner by microenterprises.
(147)
It is appropriate that the Commission facilitates, to the extent possible, access to testing and experimentation
facilities to bodies, groups or laboratories established or accredited pursuant to any relevant Union harmonisation
legislation and which fulfil tasks in the context of conformity assessment of products or devices covered by that
Union harmonisation legislation. This is, in particular, the case as regards expert panels, expert laboratories and
reference laboratories in the field of medical devices pursuant to Regulations (EU) 2017/745 and (EU) 2017/746.
(148)
This Regulation should establish a governance framework that both allows to coordinate and support the
application of this Regulation at national level, as well as build capabilities at Union level and integrate stakeholders
in the field of AI.
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2017/746.
(148)
This Regulation should establish a governance framework that both allows to coordinate and support the
application of this Regulation at national level, as well as build capabilities at Union level and integrate stakeholders
in the field of AI. The effective implementation and enforcement of this Regulation require a governance framework
that allows to coordinate and build up central expertise at Union level. The AI Office was established by Commission
Decision (45) and has as its mission to develop Union expertise and capabilities in the field of AI and to contribute to
the implementation of Union law on AI. Member States should facilitate the tasks of the AI Office with a view to
support the development of Union expertise and capabilities at Union level and to strengthen the functioning of the
digital single market. Furthermore, a Board composed of representatives of the Member States, a scientific panel to
integrate the scientific community and an advisory forum to contribute stakeholder input to the implementation of
this Regulation, at Union and national level, should be established. The development of Union expertise and
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(44)
Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124,
20.5.2003, p. 36).
(45)
Commission Decision of 24.1.2024 establishing the European Artificial Intelligence Office C(2024) 390.
capabilities should also include making use of existing resources and expertise, in particular through synergies with
structures built up in the context of the Union level enforcement of other law and synergies with related initiatives at
Union level, such as the EuroHPC Joint Undertaking and the AI testing and experimentation facilities under the
Digital Europe Programme.
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To ensure the effective and consistent implementation of this
Regulation, a
Board will be created. This
Board will represent various interests within the
AI ecosystem and will include representatives from
Member States. Its main responsibilities will include providing opinions, recommendations, and guidance on the
Regulation's implementation, enforcement, technical specifications, and existing standards. The representatives can be any qualified individuals from public entities who can help coordinate at the national level. Additionally, the
Board will form two permanent sub-groups to facilitate cooperation among
market surveillance authorities and
notified bodies. The market surveillance sub-group will function as the administrative cooperation group (ADCO) as defined in
Article 30 of Regulation (EU) 2019/1020. The
Commission will assist this sub-group by conducting market evaluations to identify areas needing urgent coordination among
market surveillance authorities. The
Board may also create other sub-groups as needed to address specific issues.
with
structures built up in the context of the Union level enforcement of other law and synergies with related initiatives at
Union level, such as the EuroHPC Joint Undertaking and the AI testing and experimentation facilities under the
Digital Europe Programme.
(149)
In order to facilitate a smooth, effective and harmonised implementation of this Regulation a Board should be
established. The Board should reflect the various interests of the AI eco-system and be composed of representatives
of the Member States. The Board should be responsible for a number of advisory tasks, including issuing opinions,
recommendations, advice or contributing to guidance on matters related to the implementation of this Regulation,
including on enforcement matters, technical specifications or existing standards regarding the requirements
established in this Regulation and providing advice to the Commission and the Member States and their national
competent authorities on specific questions related to AI. In order to give some flexibility to Member States in the
designation of their representatives in the Board, such representatives may be any persons belonging to public
entities who should have the relevant competences and powers to facilitate coordination at national level and
contribute to the achievement of the Board’s tasks. The Board should establish two standing sub-groups to provide
a platform for cooperation and exchange among market surveillance authorities and notifying authorities on issues
related, respectively, to market surveillance and notified bodies. The standing subgroup for market surveillance
should act as the administrative cooperation group (ADCO) for this Regulation within the meaning of Article 30 of
Regulation (EU) 2019/1020. In accordance with Article 33 of that Regulation, the Commission should support the
activities of the standing subgroup for market surveillance by undertaking market evaluations or studies, in
particular with a view to identifying aspects of this Regulation requiring specific and urgent coordination among
market surveillance authorities. The Board may establish other standing or temporary sub-groups as appropriate for
the purpose of examining specific issues.
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Market evaluations or studies will focus on identifying parts of this
Regulation that need urgent coordination among
market surveillance authorities. The
Board can create additional permanent or temporary sub-groups to address specific issues. It should also collaborate with relevant
Union bodies, expert groups, and networks related to
Union law, especially those concerning
data, digital products, and services.
To involve
stakeholders in implementing this
Regulation, an
advisory forum will be set up to provide advice and technical expertise to the
Board and the
Commission. This forum will ensure a balanced representation of both commercial and non-commercial interests, including industry,
start-ups,
SMEs, academia, civil society, and organizations like the
Fundamental Rights Agency,
ENISA,
CEN,
CENELEC, and
ETSI.
To aid in the implementation and enforcement of this
Regulation, especially in monitoring
general-purpose AI models, a
scientific panel of independent experts will be formed. These experts will be chosen for their current scientific or technical knowledge in
AI and will work impartially, maintaining confidentiality of any information they handle.
Member States can also seek support from this panel of experts to strengthen their enforcement efforts.
market evaluations or studies, in
particular with a view to identifying aspects of this Regulation requiring specific and urgent coordination among
market surveillance authorities. The Board may establish other standing or temporary sub-groups as appropriate for
the purpose of examining specific issues. The Board should also cooperate, as appropriate, with relevant Union
bodies, experts groups and networks active in the context of relevant Union law, including in particular those active
under relevant Union law on data, digital products and services.
(150)
With a view to ensuring the involvement of stakeholders in the implementation and application of this Regulation,
an advisory forum should be established to advise and provide technical expertise to the Board and the Commission.
To ensure a varied and balanced stakeholder representation between commercial and non-commercial interest and,
within the category of commercial interests, with regards to SMEs and other undertakings, the advisory forum
should comprise inter alia industry, start-ups, SMEs, academia, civil society, including the social partners, as well as
the Fundamental Rights Agency, ENISA, the European Committee for Standardization (CEN), the European
Committee for Electrotechnical Standardization (CENELEC) and the European Telecommunications Standards
Institute (ETSI).
(151)
To support the implementation and enforcement of this Regulation, in particular the monitoring activities of the AI
Office as regards general-purpose AI models, a scientific panel of independent experts should be established. The
independent experts constituting the scientific panel should be selected on the basis of up-to-date scientific or
technical expertise in the field of AI and should perform their tasks with impartiality, objectivity and ensure the
confidentiality of information and data obtained in carrying out their tasks and activities. To allow the reinforcement
of national capacities necessary for the effective enforcement of this Regulation, Member States should be able to
request support from the pool of experts constituting the scientific panel for their enforcement activities.
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obtained in carrying out their tasks and activities. To allow the reinforcement
of national capacities necessary for the effective enforcement of this Regulation, Member States should be able to
request support from the pool of experts constituting the scientific panel for their enforcement activities.
(152)
In order to support adequate enforcement as regards AI systems and reinforce the capacities of the Member States,
Union AI testing support structures should be established and made available to the Member States.
(153)
Member States hold a key role in the application and enforcement of this Regulation. In that respect, each Member
State should designate at least one notifying authority and at least one market surveillance authority as national
competent authorities for the purpose of supervising the application and implementation of this Regulation.
Member States may decide to appoint any kind of public entity to perform the tasks of the national competent
authorities within the meaning of this Regulation, in accordance with their specific national organisational
characteristics and needs. In order to increase organisation efficiency on the side of Member States and to set a single
point of contact vis-à-vis the public and other counterparts at Member State and Union levels, each Member State
should designate a market surveillance authority to act as a single point of contact.
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(154)
The national competent authorities should exercise their powers independently, impartially and without bias, so as
to safeguard the principles of objectivity of their activities and tasks and to ensure the application and
implementation of this Regulation. The members of these authorities should refrain from any action incompatible
with their duties and should be subject to confidentiality rules under this Regulation.
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To maintain objectivity in their work and ensure compliance with this
Regulation, members of these authorities must avoid actions that conflict with their responsibilities and adhere to confidentiality rules.
To help
providers of
high-risk AI systems improve their products and respond quickly to issues, they must implement a
post-market monitoring system. This system should analyze how their
AI interacts with other
AI systems, devices, and software, but it should not include
sensitive operational data from
law enforcement agencies. This monitoring is crucial for addressing risks from
AI systems that continue to learn after being released. Additionally,
providers must report serious incidents caused by their
AI systems to the relevant authorities. Serious incidents include those resulting in death or severe health issues, major disruptions to
critical infrastructure, violations of laws protecting
fundamental rights, or significant damage to property or the environment.
To effectively enforce the requirements of this
Regulation, the market surveillance and compliance system established by
Regulation (EU) 2019/1020 will be fully applied.
Market surveillance authorities designated under this
Regulation will have all the enforcement powers outlined in both this
Regulation and
Regulation (EU) 2019/1020, and they must carry out their duties independently and impartially.
to safeguard the principles of objectivity of their activities and tasks and to ensure the application and
implementation of this Regulation. The members of these authorities should refrain from any action incompatible
with their duties and should be subject to confidentiality rules under this Regulation.
(155)
In order to ensure that providers of high-risk AI systems can take into account the experience on the use of high-risk
AI systems for improving their systems and the design and development process or can take any possible corrective
action in a timely manner, all providers should have a post-market monitoring system in place. Where relevant,
post-market monitoring should include an analysis of the interaction with other AI systems including other devices
and software. Post-market monitoring should not cover sensitive operational data of deployers which are law
enforcement authorities. This system is also key to ensure that the possible risks emerging from AI systems which
continue to ‘learn’ after being placed on the market or put into service can be more efficiently and timely addressed.
In this context, providers should also be required to have a system in place to report to the relevant authorities any
serious incidents resulting from the use of their AI systems, meaning incident or malfunctioning leading to death or
serious damage to health, serious and irreversible disruption of the management and operation of critical
infrastructure, infringements of obligations under Union law intended to protect fundamental rights or serious
damage to property or the environment.
(156)
In order to ensure an appropriate and effective enforcement of the requirements and obligations set out by this
Regulation, which is Union harmonisation legislation, the system of market surveillance and compliance of products
established by Regulation (EU) 2019/1020 should apply in its entirety. Market surveillance authorities designated
pursuant to this Regulation should have all enforcement powers laid down in this Regulation and in Regulation (EU)
2019/1020 and should exercise their powers and carry out their duties independently, impartially and without bias.
Show original text
Surveillance authorities designated under this
Regulation must have all the enforcement powers specified in this
Regulation and in
Regulation (EU) 2019/1020. They should perform their duties independently, impartially, and without bias. While most
AI systems do not have specific requirements under this
Regulation,
market surveillance authorities can take action against any
AI systems that pose a risk according to this
Regulation. Given the unique nature of
Union institutions, agencies, and bodies covered by this
Regulation, the
European Data Protection Supervisor is designated as a competent
market surveillance authority for them. This does not affect the designation of
national authorities by
Member States. Market surveillance activities should not hinder the ability of supervised entities to perform their tasks independently when required by
Union law. This
Regulation does not interfere with the roles, responsibilities, powers, and independence of
national public authorities or bodies that oversee the application of
Union law protecting
fundamental rights, including equality bodies and
data protection authorities. These
national authorities should have access to any documents created under this
Regulation as needed for their work. A specific procedure should be established to ensure timely enforcement against
AI systems that pose risks to health, safety, and
fundamental rights. This procedure applies to
high-risk AI systems,
prohibited systems that have been improperly marketed or used, and
AI systems that violate
transparency requirements and present risks.
surveillance authorities designated
pursuant to this Regulation should have all enforcement powers laid down in this Regulation and in Regulation (EU)
2019/1020 and should exercise their powers and carry out their duties independently, impartially and without bias.
Although the majority of AI systems are not subject to specific requirements and obligations under this Regulation,
market surveillance authorities may take measures in relation to all AI systems when they present a risk in
accordance with this Regulation. Due to the specific nature of Union institutions, agencies and bodies falling within
the scope of this Regulation, it is appropriate to designate the European Data Protection Supervisor as a competent
market surveillance authority for them. This should be without prejudice to the designation of national competent
authorities by the Member States. Market surveillance activities should not affect the ability of the supervised entities
to carry out their tasks independently, when such independence is required by Union law.
(157)
This Regulation is without prejudice to the competences, tasks, powers and independence of relevant national public
authorities or bodies which supervise the application of Union law protecting fundamental rights, including equality
bodies and data protection authorities. Where necessary for their mandate, those national public authorities or
bodies should also have access to any documentation created under this Regulation. A specific safeguard procedure
should be set for ensuring adequate and timely enforcement against AI systems presenting a risk to health, safety and
fundamental rights. The procedure for such AI systems presenting a risk should be applied to high-risk AI systems
presenting a risk, prohibited systems which have been placed on the market, put into service or used in violation of
the prohibited practices laid down in this Regulation and AI systems which have been made available in violation of
the transparency requirements laid down in this Regulation and present a risk.
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which have been placed on the market, put into service or used in violation of
the prohibited practices laid down in this Regulation and AI systems which have been made available in violation of
the transparency requirements laid down in this Regulation and present a risk.
(158)
Union financial services law includes internal governance and risk-management rules and requirements which are
applicable to regulated financial institutions in the course of provision of those services, including when they make
use of AI systems. In order to ensure coherent application and enforcement of the obligations under this Regulation
and relevant rules and requirements of the Union financial services legal acts, the competent authorities for the
supervision and enforcement of those legal acts, in particular competent authorities as defined in Regulation (EU)
No 575/2013 of the European Parliament and of the Council (46) and Directives 2008/48/EC (47), 2009/138/EC (48),
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(46)
Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit
institutions and investment firms and amending Regulation (EU) No 648/2012 (OJ L 176, 27.6.2013, p. 1).
(47)
Directive 2008/48/EC of the European Parliament and of the Council of 23 April 2008 on credit agreements for consumers and
repealing Council Directive 87/102/EEC (OJ L 133, 22.5.2008, p. 66).
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The
Council issued a directive on April 23, 2008, regarding credit agreements for consumers, which replaced the previous
Council Directive 87/102/EEC. This was published in the Official Journal on May 22, 2008. Additionally,
Directive 2009/138/EC, adopted by the
European Parliament and Council on November 25, 2009, pertains to the insurance and reinsurance business (known as Solvency II) and was published in the Official Journal on December 17, 2009.
Directives 2013/36/EU, 2014/17/EU, and (EU) 2016/97 designate specific authorities to supervise the implementation of this
Regulation, particularly concerning
AI systems used by regulated financial institutions.
Member States may choose to appoint different authorities for these market surveillance tasks. These designated authorities will have the necessary powers to enforce the
Regulation's requirements, including conducting market surveillance activities that align with existing supervisory frameworks under EU financial services law.
When acting as
market surveillance authorities,
national authorities overseeing credit institutions under
Directive 2013/36/EU, which are part of the Single Supervisory Mechanism established by
Council Regulation (EU) No 1024/2013, must promptly report any relevant findings from their market surveillance to the
European Central Bank.
and of the Council of 23 April 2008 on credit agreements for consumers and
repealing Council Directive 87/102/EEC (OJ L 133, 22.5.2008, p. 66).
(48)
Directive 2009/138/EC of the European Parliament and of the Council of 25 November 2009 on the taking-up and pursuit of the
business of Insurance and Reinsurance (Solvency II) (OJ L 335, 17.12.2009, p. 1).
2013/36/EU (49), 2014/17/EU (50) and (EU) 2016/97 (51) of the European Parliament and of the Council, should be
designated, within their respective competences, as competent authorities for the purpose of supervising the
implementation of this Regulation, including for market surveillance activities, as regards AI systems provided or
used by regulated and supervised financial institutions unless Member States decide to designate another authority to
fulfil these market surveillance tasks. Those competent authorities should have all powers under this Regulation and
Regulation (EU) 2019/1020 to enforce the requirements and obligations of this Regulation, including powers to
carry our ex post market surveillance activities that can be integrated, as appropriate, into their existing supervisory
mechanisms and procedures under the relevant Union financial services law. It is appropriate to envisage that, when
acting as market surveillance authorities under this Regulation, the national authorities responsible for the
supervision of credit institutions regulated under Directive 2013/36/EU, which are participating in the Single
Supervisory Mechanism established by Council Regulation (EU) No 1024/2013 (52), should report, without delay, to
the European Central Bank any information identified in the course of their market surveillance activities that may
be of potential interest for the European Central Bank’s
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Regulation (EU) No 1024/2013 requires that any information found during market surveillance activities, which could be important for the
European Central Bank's supervisory tasks, must be reported immediately to the
European Central Bank. To improve consistency with the rules for credit institutions under
Directive 2013/36/EU, some procedural
obligations related to risk management, post-marketing monitoring, and documentation should be incorporated into the existing rules of
Directive 2013/36/EU. To prevent overlaps, some exceptions should be allowed regarding the quality management systems of
providers and the monitoring responsibilities of those using
high-risk AI systems, as long as these apply to credit institutions under
Directive 2013/36/EU. This same approach should also apply to insurance and re-insurance companies, insurance holding companies under
Directive 2009/138/EC, insurance intermediaries under Directive (EU) 2016/97, and other financial institutions that must follow internal governance and process requirements according to EU financial services laws, ensuring fairness across the financial sector. Each
market surveillance authority for
high-risk AI systems in
biometrics, as listed in an annex to this
Regulation, should have strong investigative and corrective powers. This includes the ability to access all
personal data being processed and any information needed to carry out their duties. These authorities should operate independently in exercising their powers.
Regulation (EU) No 1024/2013 (52), should report, without delay, to
the European Central Bank any information identified in the course of their market surveillance activities that may
be of potential interest for the European Central Bank’s prudential supervisory tasks as specified in that Regulation.
To further enhance the consistency between this Regulation and the rules applicable to credit institutions regulated
under Directive 2013/36/EU, it is also appropriate to integrate some of the providers’ procedural obligations in
relation to risk management, post marketing monitoring and documentation into the existing obligations and
procedures under Directive 2013/36/EU. In order to avoid overlaps, limited derogations should also be envisaged in
relation to the quality management system of providers and the monitoring obligation placed on deployers of
high-risk AI systems to the extent that these apply to credit institutions regulated by Directive 2013/36/EU. The
same regime should apply to insurance and re-insurance undertakings and insurance holding companies under
Directive 2009/138/EC and the insurance intermediaries under Directive (EU) 2016/97 and other types of financial
institutions subject to requirements regarding internal governance, arrangements or processes established pursuant
to the relevant Union financial services law to ensure consistency and equal treatment in the financial sector.
(159)
Each market surveillance authority for high-risk AI systems in the area of biometrics, as listed in an annex to this
Regulation insofar as those systems are used for the purposes of law enforcement, migration, asylum and border
control management, or the administration of justice and democratic processes, should have effective investigative
and corrective powers, including at least the power to obtain access to all personal data that are being processed and
to all information necessary for the performance of its tasks. The market surveillance authorities should be able to
exercise their powers by acting with complete independence.
Show original text
Market surveillance authorities must have the power to access all
personal data being processed and any information needed to perform their duties. They should operate independently, and any restrictions on their access to
sensitive operational data under this
Regulation should not affect their powers granted by
Directive (EU) 2016/680. Additionally, any limitations on sharing
data with national
data protection authorities should not impact their current or future powers outside this
Regulation.
Market surveillance authorities and the
Commission can propose joint activities, such as joint investigations, to ensure compliance, identify non-compliance, raise awareness, and provide guidance regarding this
Regulation, especially for
high-risk AI systems that pose serious risks across multiple
Member States. These joint compliance activities should follow
Article 9 of
Regulation (EU) 2019/1020, with the
AI Office offering coordination support.
It is important to clarify the roles and responsibilities at both the
Union and national levels for
AI systems based on
general-purpose AI models. To prevent overlapping responsibilities, if an
AI system is based on a
general-purpose AI model provided by the same supplier, supervision should be streamlined.
corrective powers, including at least the power to obtain access to all personal data that are being processed and
to all information necessary for the performance of its tasks. The market surveillance authorities should be able to
exercise their powers by acting with complete independence. Any limitations of their access to sensitive operational
data under this Regulation should be without prejudice to the powers conferred to them by Directive
(EU) 2016/680. No exclusion on disclosing data to national data protection authorities under this Regulation should
affect the current or future powers of those authorities beyond the scope of this Regulation.
(160)
The market surveillance authorities and the Commission should be able to propose joint activities, including joint
investigations, to be conducted by market surveillance authorities or market surveillance authorities jointly with the
Commission, that have the aim of promoting compliance, identifying non-compliance, raising awareness and
providing guidance in relation to this Regulation with respect to specific categories of high-risk AI systems that are
found to present a serious risk across two or more Member States. Joint activities to promote compliance should be
carried out in accordance with Article 9 of Regulation (EU) 2019/1020. The AI Office should provide coordination
support for joint investigations.
(161)
It is necessary to clarify the responsibilities and competences at Union and national level as regards AI systems that
are built on general-purpose AI models. To avoid overlapping competences, where an AI system is based on
a general-purpose AI model and the model and system are provided by the same provider, the supervision should
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Show original text
To prevent overlapping responsibilities, when an
AI system uses a
general-purpose AI model from the same
provider, supervision should be implemented. This is in accordance with various directives and regulations, including:
1.
Directive 2013/36/EU from the
European Parliament and Council, dated June 26, 2013, which addresses access to credit institutions and their supervision, while amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC.
2.
Directive 2014/17/EU from the
European Parliament and Council, dated February 4, 2014, which focuses on credit agreements for consumers related to residential property, amending Directives 2008/48/EC and 2013/36/EU and
Regulation (EU) No 1093/2010.
3. Directive (EU) 2016/97 from the
European Parliament and Council, dated January 20, 2016, concerning insurance distribution.
4.
Council Regulation (EU) No 1024/2013, dated October 15, 2013, which assigns specific tasks to the
European Central Bank regarding the prudential supervision of credit institutions.
-purpose AI models. To avoid overlapping competences, where an AI system is based on
a general-purpose AI model and the model and system are provided by the same provider, the supervision should
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(49)
Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions
and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing
Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338).
(50)
Directive 2014/17/EU of the European Parliament and of the Council of 4 February 2014 on credit agreements for consumers
relating to residential immovable property and amending Directives 2008/48/EC and 2013/36/EU and Regulation (EU)
No 1093/2010 (OJ L 60, 28.2.2014, p. 34).
(51)
Directive (EU) 2016/97 of the European Parliament and of the Council of 20 January 2016 on insurance distribution (OJ L 26,
2.2.2016, p. 19).
(52)
Council Regulation (EU) No 1024/2013 of 15 October 2013 conferring specific tasks on the European Central Bank concerning
policies relating to the prudential supervision of credit institutions (OJ L 287, 29.10.2013, p. 63).
Show original text
On 15 October 2013, specific tasks were assigned to the
European Central Bank regarding the prudential supervision of credit institutions (Official Journal L 287, 29.10.2013, p. 63).
At the
Union level, the
AI Office will act as a
market surveillance authority as defined by
Regulation (EU) 2019/1020. National
market surveillance authorities will still oversee
AI systems in most cases. However, for
general-purpose AI systems that can be used for at least one high-risk purpose, these authorities must work with the
AI Office to evaluate compliance and inform the
Board and other authorities. If a
market surveillance authority cannot complete an investigation on a
high-risk AI system due to lack of access to information about the
general-purpose AI model it is based on, they can request help from the
AI Office. In such situations, the mutual assistance procedures outlined in
Chapter VI of Regulation (EU) 2019/1020 will apply.
To effectively utilize
Union expertise, the
Commission should have the authority to supervise and enforce
obligations on
providers of
general-purpose AI models. The
AI Office will monitor the implementation of this
Regulation regarding these models and can investigate potential violations either on its own or at the request of
market surveillance authorities, as specified in this
Regulation.
of 15 October 2013 conferring specific tasks on the European Central Bank concerning
policies relating to the prudential supervision of credit institutions (OJ L 287, 29.10.2013, p. 63).
take place at Union level through the AI Office, which should have the powers of a market surveillance authority
within the meaning of Regulation (EU) 2019/1020 for this purpose. In all other cases, national market surveillance
authorities remain responsible for the supervision of AI systems. However, for general-purpose AI systems that can
be used directly by deployers for at least one purpose that is classified as high-risk, market surveillance authorities
should cooperate with the AI Office to carry out evaluations of compliance and inform the Board and other market
surveillance authorities accordingly. Furthermore, market surveillance authorities should be able to request
assistance from the AI Office where the market surveillance authority is unable to conclude an investigation on
a high-risk AI system because of its inability to access certain information related to the general-purpose AI model
on which the high-risk AI system is built. In such cases, the procedure regarding mutual assistance in cross-border
cases in Chapter VI of Regulation (EU) 2019/1020 should apply mutatis mutandis.
(162)
To make best use of the centralised Union expertise and synergies at Union level, the powers of supervision and
enforcement of the obligations on providers of general-purpose AI models should be a competence of the
Commission. The AI Office should be able to carry out all necessary actions to monitor the effective implementation
of this Regulation as regards general-purpose AI models. It should be able to investigate possible infringements of
the rules on providers of general-purpose AI models both on its own initiative, following the results of its
monitoring activities, or upon request from market surveillance authorities in line with the conditions set out in this
Regulation.
Show original text
possible infringements of
the rules on providers of general-purpose AI models both on its own initiative, following the results of its
monitoring activities, or upon request from market surveillance authorities in line with the conditions set out in this
Regulation. To support effective monitoring of the AI Office, it should provide for the possibility that downstream
providers lodge complaints about possible infringements of the rules on providers of general-purpose AI models and
systems.
(163)
With a view to complementing the governance systems for general-purpose AI models, the scientific panel should
support the monitoring activities of the AI Office and may, in certain cases, provide qualified alerts to the AI Office
which trigger follow-ups, such as investigations. This should be the case where the scientific panel has reason to
suspect that a general-purpose AI model poses a concrete and identifiable risk at Union level. Furthermore, this
should be the case where the scientific panel has reason to suspect that a general-purpose AI model meets the criteria
that would lead to a classification as general-purpose AI model with systemic risk. To equip the scientific panel with
the information necessary for the performance of those tasks, there should be a mechanism whereby the scientific
panel can request the Commission to require documentation or information from a provider.
(164)
The AI Office should be able to take the necessary actions to monitor the effective implementation of and
compliance with the obligations for providers of general-purpose AI models laid down in this Regulation. The AI
Office should be able to investigate possible infringements in accordance with the powers provided for in this
Regulation, including by requesting documentation and information, by conducting evaluations, as well as by
requesting measures from providers of general-purpose AI models. When conducting evaluations, in order to make
use of independent expertise, the AI Office should be able to involve independent experts to carry out the
evaluations on its behalf.
Show original text
The
AI Office can request measures from
providers of
general-purpose AI models and involve independent experts for evaluations. Compliance with
obligations can be enforced through requests for appropriate actions, such as risk mitigation for identified
systemic risks, or by restricting, withdrawing, or recalling the
AI model. Additionally,
providers of
general-purpose AI models should have procedural rights as outlined in
Article 18 of Regulation (EU) 2019/1020, which will apply similarly, without affecting more specific rights in this
Regulation.
Developing
AI systems that are not classified as high-risk, according to this
Regulation, may promote the use of ethical and trustworthy
AI in the EU.
Providers of non-
high-risk AI systems should be encouraged to create
codes of conduct and governance mechanisms to voluntarily adopt some or all mandatory requirements for
high-risk AI systems, tailored to their lower risk and intended purpose, while considering available
technical solutions and industry best practices like
model and data cards. All
providers and deployers of
AI systems, whether high-risk or not, should also be encouraged to voluntarily follow additional requirements related to the EU’s
Ethics Guidelines for Trustworthy AI.
well as by
requesting measures from providers of general-purpose AI models. When conducting evaluations, in order to make
use of independent expertise, the AI Office should be able to involve independent experts to carry out the
evaluations on its behalf. Compliance with the obligations should be enforceable, inter alia, through requests to take
appropriate measures, including risk mitigation measures in the case of identified systemic risks as well as restricting
the making available on the market, withdrawing or recalling the model. As a safeguard, where needed beyond the
procedural rights provided for in this Regulation, providers of general-purpose AI models should have the
procedural rights provided for in Article 18 of Regulation (EU) 2019/1020, which should apply mutatis mutandis,
without prejudice to more specific procedural rights provided for by this Regulation.
(165)
The development of AI systems other than high-risk AI systems in accordance with the requirements of this
Regulation may lead to a larger uptake of ethical and trustworthy AI in the Union. Providers of AI systems that are
not high-risk should be encouraged to create codes of conduct, including related governance mechanisms, intended
to foster the voluntary application of some or all of the mandatory requirements applicable to high-risk AI systems,
adapted in light of the intended purpose of the systems and the lower risk involved and taking into account the
available technical solutions and industry best practices such as model and data cards. Providers and, as appropriate,
deployers of all AI systems, high-risk or not, and AI models should also be encouraged to apply on a voluntary basis
additional requirements related, for example, to the elements of the Union’s Ethics Guidelines for Trustworthy AI,
OJ L, 12.7.
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AI models, whether high-risk or not, should voluntarily follow additional guidelines based on the
Union’s Ethics Guidelines for Trustworthy AI. These guidelines include promoting
environmental sustainability, improving
AI literacy, and ensuring
inclusive and diverse design and development of
AI systems. This means paying attention to
vulnerable groups and making systems accessible for people with disabilities. It is also important to involve various
stakeholders, such as businesses, civil society organizations, academia, research institutions, trade unions, and consumer protection groups, in the design and development of
AI systems. Diversity in development teams, including gender balance, is essential. To ensure that voluntary
codes of conduct are effective, they should have clear goals and
key performance indicators to measure success. The
European Commission may create initiatives to reduce technical barriers that hinder cross-border
data exchange for
AI development, focusing on
data access and interoperability. Additionally,
AI systems that are not classified as high-risk must still be safe when marketed or used.
Regulation (EU) 2023/988 will serve as a safety net for this purpose.
high-risk or not, and AI models should also be encouraged to apply on a voluntary basis
additional requirements related, for example, to the elements of the Union’s Ethics Guidelines for Trustworthy AI,
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environmental sustainability, AI literacy measures, inclusive and diverse design and development of AI systems,
including attention to vulnerable persons and accessibility to persons with disability, stakeholders’ participation with
the involvement, as appropriate, of relevant stakeholders such as business and civil society organisations, academia,
research organisations, trade unions and consumer protection organisations in the design and development of AI
systems, and diversity of the development teams, including gender balance. To ensure that the voluntary codes of
conduct are effective, they should be based on clear objectives and key performance indicators to measure the
achievement of those objectives. They should also be developed in an inclusive way, as appropriate, with the
involvement of relevant stakeholders such as business and civil society organisations, academia, research
organisations, trade unions and consumer protection organisation. The Commission may develop initiatives,
including of a sectoral nature, to facilitate the lowering of technical barriers hindering cross-border exchange of data
for AI development, including on data access infrastructure, semantic and technical interoperability of different types
of data.
(166)
It is important that AI systems related to products that are not high-risk in accordance with this Regulation and thus
are not required to comply with the requirements set out for high-risk AI systems are nevertheless safe when placed
on the market or put into service. To contribute to this objective, Regulation (EU) 2023/988 of the European
Parliament and of the Council (53) would apply as a safety net.
Show original text
Systems are considered safe when they are sold or used. To support this,
Regulation (EU) 2023/988 from the
European Parliament and Council acts as a safety measure. To ensure effective cooperation among authorities at both the EU and national levels, all parties involved must keep information and
data confidential, following EU or national laws. They must protect
intellectual property rights,
confidential business information,
trade secrets, public and national security, and the integrity of legal proceedings and classified information. Compliance with this
Regulation can be enforced through penalties and other measures.
Member States must ensure the
Regulation is followed by establishing effective and proportionate penalties for violations, while respecting the principle of ne bis in idem (not being tried twice for the same offense). To standardize penalties, specific upper limits for administrative fines for certain violations will be set. When determining fines,
Member States should consider the specific circumstances, including the nature and seriousness of the violation, its duration, its consequences, and the size of the
provider, especially if it is a small or start-up business. The
European Data Protection Supervisor can impose fines on EU institutions, agencies, and bodies covered by this
Regulation.
systems are nevertheless safe when placed
on the market or put into service. To contribute to this objective, Regulation (EU) 2023/988 of the European
Parliament and of the Council (53) would apply as a safety net.
(167)
In order to ensure trustful and constructive cooperation of competent authorities on Union and national level, all
parties involved in the application of this Regulation should respect the confidentiality of information and data
obtained in carrying out their tasks, in accordance with Union or national law. They should carry out their tasks and
activities in such a manner as to protect, in particular, intellectual property rights, confidential business information
and trade secrets, the effective implementation of this Regulation, public and national security interests, the integrity
of criminal and administrative proceedings, and the integrity of classified information.
(168)
Compliance with this Regulation should be enforceable by means of the imposition of penalties and other
enforcement measures. Member States should take all necessary measures to ensure that the provisions of this
Regulation are implemented, including by laying down effective, proportionate and dissuasive penalties for their
infringement, and to respect the ne bis in idem principle. In order to strengthen and harmonise administrative
penalties for infringement of this Regulation, the upper limits for setting the administrative fines for certain specific
infringements should be laid down. When assessing the amount of the fines, Member States should, in each
individual case, take into account all relevant circumstances of the specific situation, with due regard in particular to
the nature, gravity and duration of the infringement and of its consequences and to the size of the provider, in
particular if the provider is an SME, including a start-up. The European Data Protection Supervisor should have the
power to impose fines on Union institutions, agencies and bodies falling within the scope of this Regulation.
Show original text
The size of the
provider matters, especially if it is a small or medium-sized enterprise (SME) or a start-up. The
European Data Protection Supervisor should be able to impose fines on EU institutions, agencies, and bodies under this
Regulation. Compliance with the rules for
providers of
general-purpose AI models should be enforceable through fines. There should be specific fine amounts for not following these rules, including not complying with requests from the
Commission, while ensuring that these fines are fair and proportional. All decisions made by the
Commission under this
Regulation can be reviewed by the
Court of Justice of the European Union, which has the authority to impose penalties as outlined in Article 261 of the
TFEU. Existing EU and national laws already offer effective remedies for individuals and organizations whose rights are negatively impacted by
AI systems. In addition to these remedies, anyone who believes their rights have been violated by this
Regulation can file a complaint with the appropriate
market surveillance authority. Individuals affected by decisions based on outputs from certain
high-risk AI systems should have the right to receive an explanation, especially if those decisions have significant legal effects or negatively impact them.
the size of the provider, in
particular if the provider is an SME, including a start-up. The European Data Protection Supervisor should have the
power to impose fines on Union institutions, agencies and bodies falling within the scope of this Regulation.
(169)
Compliance with the obligations on providers of general-purpose AI models imposed under this Regulation should
be enforceable, inter alia, by means of fines. To that end, appropriate levels of fines should also be laid down for
infringement of those obligations, including the failure to comply with measures requested by the Commission in
accordance with this Regulation, subject to appropriate limitation periods in accordance with the principle of
proportionality. All decisions taken by the Commission under this Regulation are subject to review by the Court of
Justice of the European Union in accordance with the TFEU, including the unlimited jurisdiction of the Court of
Justice with regard to penalties pursuant to Article 261 TFEU.
(170)
Union and national law already provide effective remedies to natural and legal persons whose rights and freedoms
are adversely affected by the use of AI systems. Without prejudice to those remedies, any natural or legal person that
has grounds to consider that there has been an infringement of this Regulation should be entitled to lodge
a complaint to the relevant market surveillance authority.
(171)
Affected persons should have the right to obtain an explanation where a deployer’s decision is based mainly upon
the output from certain high-risk AI systems that fall within the scope of this Regulation and where that decision
produces legal effects or similarly significantly affects those persons in a way that they consider to have an adverse
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OJ L, 12.7.
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Certain
high-risk AI systems covered by this
Regulation must provide clear explanations when their decisions have legal effects or significantly impact individuals in ways they view as harmful to their health, safety, or
fundamental rights. This explanation should help affected individuals understand their rights. However, the right to an explanation does not apply to
AI systems that are exempt or restricted by
Union or national law, and it only applies if this right is not already established by
Union law. Additionally, whistleblowers who report violations of this
Regulation should be protected under
Union law, specifically under
Directive (EU) 2019/1937, which
safeguards those reporting such violations.
certain high-risk AI systems that fall within the scope of this Regulation and where that decision
produces legal effects or similarly significantly affects those persons in a way that they consider to have an adverse
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(53)
Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety, amending
Regulation (EU) No 1025/2012 of the European Parliament and of the Council and Directive (EU) 2020/1828 of the European
Parliament and the Council, and repealing Directive 2001/95/EC of the European Parliament and of the Council and Council
Directive 87/357/EEC (OJ L 135, 23.5.2023, p. 1).
impact on their health, safety or fundamental rights. That explanation should be clear and meaningful and should
provide a basis on which the affected persons are able to exercise their rights. The right to obtain an explanation
should not apply to the use of AI systems for which exceptions or restrictions follow from Union or national law
and should apply only to the extent this right is not already provided for under Union law.
(172)
Persons acting as whistleblowers on the infringements of this Regulation should be protected under the Union law.
Directive (EU) 2019/1937 of the European Parliament and of the Council (54) should therefore apply to the reporting
of infringements of this Regulation and the protection of persons reporting such infringements.
Show original text
Under
Union law,
Directive (EU) 2019/1937 from the
European Parliament and Council applies to reporting violations of this
Regulation and protecting those who report such violations. To ensure the regulatory framework can be updated as needed, the
Commission is given the authority to make changes regarding which
AI systems are classified as high-risk, the list of
high-risk AI systems,
technical documentation requirements, the
EU declaration of conformity, and
conformity assessment procedures. This includes setting thresholds,
benchmarks, and indicators for classifying
general-purpose AI models with systemic risk, as well as criteria for designating these models and providing necessary
technical documentation and
transparency information. It is crucial that the
Commission consults appropriately during this process, including engaging with experts, and follows the principles of the Interinstitutional Agreement on Better Law-Making from April 13, 2016. To ensure equal participation, the
European Parliament and the
Council should receive all relevant documents simultaneously with
Member States’ experts, and their experts should have access to
Commission expert group meetings related to these delegated acts.
under the Union law.
Directive (EU) 2019/1937 of the European Parliament and of the Council (54) should therefore apply to the reporting
of infringements of this Regulation and the protection of persons reporting such infringements.
(173)
In order to ensure that the regulatory framework can be adapted where necessary, the power to adopt acts in
accordance with Article 290 TFEU should be delegated to the Commission to amend the conditions under which an
AI system is not to be considered to be high-risk, the list of high-risk AI systems, the provisions regarding technical
documentation, the content of the EU declaration of conformity the provisions regarding the conformity assessment
procedures, the provisions establishing the high-risk AI systems to which the conformity assessment procedure
based on assessment of the quality management system and assessment of the technical documentation should
apply, the threshold, benchmarks and indicators, including by supplementing those benchmarks and indicators, in
the rules for the classification of general-purpose AI models with systemic risk, the criteria for the designation of
general-purpose AI models with systemic risk, the technical documentation for providers of general-purpose AI
models and the transparency information for providers of general-purpose AI models. It is of particular importance
that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and
that those consultations be conducted in accordance with the principles laid down in the Interinstitutional
Agreement of 13 April 2016 on Better Law-Making (55). In particular, to ensure equal participation in the
preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as
Member States’ experts, and their experts systematically have access to meetings of Commission expert groups
dealing with the preparation of delegated acts.
Show original text
When preparing delegated acts, the
European Parliament and the
Council receive all documents simultaneously with experts from
Member States. These experts also have regular access to meetings of
Commission expert groups involved in preparing these acts.
Due to rapid technological advancements and the expertise needed to effectively implement this
Regulation, the
Commission must evaluate and review it by August 2, 2029, and every four years after that, reporting to the
European Parliament and the
Council. Additionally, the
Commission should assess annually whether to update the list of
high-risk AI systems and prohibited practices. By August 2, 2028, and every four years thereafter, the
Commission must evaluate and report on the need to amend the list of high-risk areas, the
AI systems subject to
transparency obligations, the effectiveness of supervision and governance, and progress on developing standards for energy-efficient
general-purpose AI models, including any further necessary actions. Furthermore, by August 2, 2028, and every three years thereafter, the
Commission should assess the impact and effectiveness of voluntary
codes of conduct aimed at promoting compliance with requirements for
high-risk AI systems, as well as any additional requirements for other
AI systems.
To ensure consistent implementation of this
Regulation, the
Commission will be granted implementing powers, which will be exercised in accordance with
Regulation (EU) No 182/2011 of the
European Parliament and the
Council.
the
preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as
Member States’ experts, and their experts systematically have access to meetings of Commission expert groups
dealing with the preparation of delegated acts.
(174)
Given the rapid technological developments and the technical expertise required to effectively apply this Regulation,
the Commission should evaluate and review this Regulation by 2 August 2029 and every four years thereafter and
report to the European Parliament and the Council. In addition, taking into account the implications for the scope of
this Regulation, the Commission should carry out an assessment of the need to amend the list of high-risk AI
systems and the list of prohibited practices once a year. Moreover, by 2 August 2028 and every four years thereafter,
the Commission should evaluate and report to the European Parliament and to the Council on the need to amend
the list of high-risk areas headings in the annex to this Regulation, the AI systems within the scope of the
transparency obligations, the effectiveness of the supervision and governance system and the progress on the
development of standardisation deliverables on energy efficient development of general-purpose AI models,
including the need for further measures or actions. Finally, by 2 August 2028 and every three years thereafter, the
Commission should evaluate the impact and effectiveness of voluntary codes of conduct to foster the application of
the requirements provided for high-risk AI systems in the case of AI systems other than high-risk AI systems and
possibly other additional requirements for such AI systems.
(175)
In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be
conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011
of the European Parliament and of the Council (56).
Show original text
To ensure consistent application of this
Regulation, the
European Commission will be given specific powers to implement it, following the guidelines of
Regulation (EU) No 182/2011. The main goal of this
Regulation is to enhance the
internal market and encourage the use of human-centered and trustworthy
AI, while also protecting health, safety, and
fundamental rights as outlined in the
Charter. This includes upholding democracy, the rule of law, and environmental protection against the negative impacts of
AI systems in the EU. Since individual
Member States cannot achieve these objectives effectively on their own, it is better for the EU to take action at a
Union level, in line with the principle of subsidiarity stated in
Article 5 TEU.
uniform conditions for the implementation of this Regulation, implementing powers should be
conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011
of the European Parliament and of the Council (56).
(176)
Since the objective of this Regulation, namely to improve the functioning of the internal market and to promote the
uptake of human centric and trustworthy AI, while ensuring a high level of protection of health, safety, fundamental
rights enshrined in the Charter, including democracy, the rule of law and environmental protection against harmful
effects of AI systems in the Union and supporting innovation, cannot be sufficiently achieved by the Member States
and can rather, by reason of the scale or effects of the action, be better achieved at Union level, the Union may adopt
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(54)
Directive (EU) 2019/1937 of the European Parliament and of the Council of 23 October 2019 on the protection of persons who
report breaches of Union law (OJ L 305, 26.11.2019, p. 17).
(55)
OJ L 123, 12.5.2016, p. 1.
(56)
Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and
general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ
L 55, 28.2.2011, p. 13).
measures in accordance with the principle of subsidiarity as set out in Article 5 TEU.
Show original text
The
Commission's implementation powers are outlined in the Official Journal (
OJ L 55, 28.2.2011, p. 13). This
regulation follows the principle of subsidiarity from
Article 5 of the Treaty on
European Union (
TEU) and adheres to the principle of proportionality, meaning it does not exceed what is necessary to achieve its goals. To provide legal certainty and allow operators time to adapt without disrupting the market, this
regulation will apply to
high-risk AI systems that were already on the market before the
regulation's general application date, but only if those systems undergo significant changes in design or purpose after that date. 'Significant change' is defined similarly to '
substantial modification' for
high-risk AI systems under this
regulation. Additionally, operators of
AI systems that are part of large-scale IT systems specified in an annex to this
regulation, as well as those using
high-risk AI systems for
public authorities, must comply with the
regulation by the end of 2030 and by August 2, 2030, respectively.
Providers of
high-risk AI systems are encouraged to voluntarily start complying with the
regulation during the transitional period. This
regulation will take effect on August 2, 2026.
States of the Commission’s exercise of implementing powers (OJ
L 55, 28.2.2011, p. 13).
measures in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the
principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order
to achieve that objective.
(177)
In order to ensure legal certainty, ensure an appropriate adaptation period for operators and avoid disruption to the
market, including by ensuring continuity of the use of AI systems, it is appropriate that this Regulation applies to the
high-risk AI systems that have been placed on the market or put into service before the general date of application
thereof, only if, from that date, those systems are subject to significant changes in their design or intended purpose.
It is appropriate to clarify that, in this respect, the concept of significant change should be understood as equivalent
in substance to the notion of substantial modification, which is used with regard only to high-risk AI systems
pursuant to this Regulation. On an exceptional basis and in light of public accountability, operators of AI systems
which are components of the large-scale IT systems established by the legal acts listed in an annex to this Regulation
and operators of high-risk AI systems that are intended to be used by public authorities should, respectively, take the
necessary steps to comply with the requirements of this Regulation by end of 2030 and by 2 August 2030.
(178)
Providers of high-risk AI systems are encouraged to start to comply, on a voluntary basis, with the relevant
obligations of this Regulation already during the transitional period.
(179)
This Regulation should apply from 2 August 2026.
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Providers of
high-risk AI systems are encouraged to voluntarily start following the rules of this
Regulation during the transitional period. This
Regulation will officially take effect on August 2, 2026. However, due to the high risks associated with certain uses of
AI, some prohibitions and general rules will take effect earlier, on February 2, 2025. While the full enforcement of these prohibitions will depend on the establishment of governance and enforcement mechanisms, it is important to implement them early to address unacceptable risks and influence other legal processes. Additionally, the governance infrastructure and
conformity assessment system should be operational by August 2, 2026, which means the rules regarding
notified bodies and governance will start on August 2, 2025. Given the rapid development of
general-purpose AI models,
obligations for their
providers will also begin on August 2, 2025.
Codes of practice must be ready by May 2, 2025, to help
providers demonstrate compliance on time. The
AI Office will ensure that classification rules and procedures are updated according to technological advancements. Furthermore,
Member States need to establish and inform the
Commission about penalty rules, including administrative fines, and ensure their effective implementation by the
Regulation's application date. Thus, the penalty provisions will take effect on August 2, 2025.
)
Providers of high-risk AI systems are encouraged to start to comply, on a voluntary basis, with the relevant
obligations of this Regulation already during the transitional period.
(179)
This Regulation should apply from 2 August 2026. However, taking into account the unacceptable risk associated
with the use of AI in certain ways, the prohibitions as well as the general provisions of this Regulation should already
apply from 2 February 2025. While the full effect of those prohibitions follows with the establishment of the
governance and enforcement of this Regulation, anticipating the application of the prohibitions is important to take
account of unacceptable risks and to have an effect on other procedures, such as in civil law. Moreover, the
infrastructure related to the governance and the conformity assessment system should be operational before
2 August 2026, therefore the provisions on notified bodies and governance structure should apply from 2 August
2025. Given the rapid pace of technological advancements and adoption of general-purpose AI models, obligations
for providers of general-purpose AI models should apply from 2 August 2025. Codes of practice should be ready by
2 May 2025 in view of enabling providers to demonstrate compliance on time. The AI Office should ensure that
classification rules and procedures are up to date in light of technological developments. In addition, Member States
should lay down and notify to the Commission the rules on penalties, including administrative fines, and ensure that
they are properly and effectively implemented by the date of application of this Regulation. Therefore the provisions
on penalties should apply from 2 August 2025.
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The
Commission must establish and notify the rules regarding penalties, including administrative fines, and ensure their effective implementation by the time this
Regulation takes effect. Therefore, the penalty provisions will be in effect starting from August 2, 2025.
The
European Data Protection Supervisor and the
European Data Protection Board were consulted as required by Article 42(1) and (2) of
Regulation (EU) 2018/1725, and they provided their joint opinion on June 18, 2021.
This
Regulation aims to enhance the
internal market and encourage the use of trustworthy, human-centered artificial intelligence (
AI), while ensuring strong protection for health, safety,
fundamental rights, democracy, the rule of law, and environmental safety against the negative impacts of
AI systems in the EU, while also fostering innovation.
The
Regulation includes:
(a) standardized rules for marketing, deploying, and using
AI systems in the EU;
(b) bans on certain
AI practices;
(c) specific requirements and
obligations for
high-risk AI systems;
(d) standardized
transparency rules for certain
AI systems;
(e) standardized rules for marketing
general-purpose AI models;
(f) rules for market monitoring, surveillance, governance, and enforcement;
(g) measures to support innovation, especially for small and medium-sized enterprises (
SMEs) and
start-ups.
down and notify to the Commission the rules on penalties, including administrative fines, and ensure that
they are properly and effectively implemented by the date of application of this Regulation. Therefore the provisions
on penalties should apply from 2 August 2025.
(180)
The European Data Protection Supervisor and the European Data Protection Board were consulted in accordance
with Article 42(1) and (2) of Regulation (EU) 2018/1725 and delivered their joint opinion on 18 June 2021,
HAVE ADOPTED THIS REGULATION:
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter`
1.
The purpose of this Regulation is to improve the functioning of the internal market and promote the uptake of
human-centric and trustworthy artificial intelligence (AI), while ensuring a high level of protection of health, safety,
fundamental rights enshrined in the Charter, including democracy, the rule of law and environmental protection, against
the harmful effects of AI systems in the Union and supporting innovation.
2.
This Regulation lays down:
(a) harmonised rules for the placing on the market, the putting into service, and the use of AI systems in the Union;
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(b) prohibitions of certain AI practices;
(c) specific requirements for high-risk AI systems and obligations for operators of such systems;
(d) harmonised transparency rules for certain AI systems;
(e) harmonised rules for the placing on the market of general-purpose AI models;
(f) rules on market monitoring, market surveillance, governance and enforcement;
(g) measures to support innovation, with a particular focus on SMEs, including start-ups.
Article 2
Scope
1.
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on the market of general-purpose AI models;
(f) rules on market monitoring, market surveillance, governance and enforcement;
(g) measures to support innovation, with a particular focus on SMEs, including start-ups.
Article 2
Scope
1.
This Regulation applies to:
(a) providers placing on the market or putting into service AI systems or placing on the market general-purpose AI models
in the Union, irrespective of whether those providers are established or located within the Union or in a third country;
(b) deployers of AI systems that have their place of establishment or are located within the Union;
(c) providers and deployers of AI systems that have their place of establishment or are located in a third country, where the
output produced by the AI system is used in the Union;
(d) importers and distributors of AI systems;
(e) product manufacturers placing on the market or putting into service an AI system together with their product and
under their own name or trademark;
(f) authorised representatives of providers, which are not established in the Union;
(g) affected persons that are located in the Union.
2.
For AI systems classified as high-risk AI systems in accordance with Article 6(1) related to products covered by the
Union harmonisation legislation listed in Section B of Annex I, only Article 6(1), Articles 102 to 109 and Article 112 apply.
Article 57 applies only in so far as the requirements for high-risk AI systems under this Regulation have been integrated in
that Union harmonisation legislation.
3.
This Regulation does not apply to areas outside the scope of Union law, and shall not, in any event, affect the
competences of the Member States concerning national security, regardless of the type of entity entrusted by the Member
States with carrying out tasks in relation to those competences.
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Union law does not affect the powers of
Member States regarding national security, regardless of who they assign to handle those responsibilities. This
Regulation does not cover
AI systems that are marketed, used, or modified solely for military, defense, or national security purposes, no matter who is involved. It also does not apply to
AI systems that are not sold or used in the
Union if their results are only for military, defense, or national security purposes. Additionally, this
Regulation does not apply to
public authorities in other countries or international organizations that use
AI for
law enforcement or judicial cooperation with the
Union, as long as they ensure adequate protection of individual rights. Furthermore, this
Regulation does not change the liability rules for
providers of intermediary services as outlined in
Regulation (EU) 2022/2065. Lastly, it does not apply to
AI systems or models created specifically for
scientific research and development.
the scope of Union law, and shall not, in any event, affect the
competences of the Member States concerning national security, regardless of the type of entity entrusted by the Member
States with carrying out tasks in relation to those competences.
This Regulation does not apply to AI systems where and in so far they are placed on the market, put into service, or used
with or without modification exclusively for military, defence or national security purposes, regardless of the type of entity
carrying out those activities.
This Regulation does not apply to AI systems which are not placed on the market or put into service in the Union, where
the output is used in the Union exclusively for military, defence or national security purposes, regardless of the type of
entity carrying out those activities.
4.
This Regulation applies neither to public authorities in a third country nor to international organisations falling
within the scope of this Regulation pursuant to paragraph 1, where those authorities or organisations use AI systems in the
framework of international cooperation or agreements for law enforcement and judicial cooperation with the Union or
with one or more Member States, provided that such a third country or international organisation provides adequate
safeguards with respect to the protection of fundamental rights and freedoms of individuals.
5.
This Regulation shall not affect the application of the provisions on the liability of providers of intermediary services
as set out in Chapter II of Regulation (EU) 2022/2065.
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6.
This Regulation does not apply to AI systems or AI models, including their output, specifically developed and put into
service for the sole purpose of scientific research and development.
7.
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This
Regulation does not cover
AI systems or models created solely for
scientific research and development. It also does not affect existing laws on
personal data protection, such as
Regulation (EU) 2016/679,
Regulation (EU) 2018/1725,
Directive 2002/58/EC, or
Regulation (EU) 2016/680, except for specific articles in this
Regulation. Additionally, the
Regulation does not apply to research, testing, or development of
AI systems before they are marketed or used, although real-world testing is not excluded. It does not interfere with other EU laws related to consumer protection and product safety. Furthermore, it does not impose
obligations on individuals using
AI systems for personal, non-professional purposes. The
Regulation allows the EU or
Member States to create laws that better protect workers' rights regarding
AI use by employers, and it does not apply to
AI systems released under free and open-source licenses unless they are classified as high-risk or fall under specific articles.
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6.
This Regulation does not apply to AI systems or AI models, including their output, specifically developed and put into
service for the sole purpose of scientific research and development.
7.
Union law on the protection of personal data, privacy and the confidentiality of communications applies to personal
data processed in connection with the rights and obligations laid down in this Regulation. This Regulation shall not affect
Regulation (EU) 2016/679 or (EU) 2018/1725, or Directive 2002/58/EC or (EU) 2016/680, without prejudice to Article
10(5) and Article 59 of this Regulation.
8.
This Regulation does not apply to any research, testing or development activity regarding AI systems or AI models
prior to their being placed on the market or put into service. Such activities shall be conducted in accordance with
applicable Union law. Testing in real world conditions shall not be covered by that exclusion.
9.
This Regulation is without prejudice to the rules laid down by other Union legal acts related to consumer protection
and product safety.
10.
This Regulation does not apply to obligations of deployers who are natural persons using AI systems in the course of
a purely personal non-professional activity.
11.
This Regulation does not preclude the Union or Member States from maintaining or introducing laws, regulations or
administrative provisions which are more favourable to workers in terms of protecting their rights in respect of the use of
AI systems by employers, or from encouraging or allowing the application of collective agreements which are more
favourable to workers.
12.
This Regulation does not apply to AI systems released under free and open-source licences, unless they are placed on
the market or put into service as high-risk AI systems or as an AI system that falls under Article 5 or 50.
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This
Regulation does not apply to
AI systems that are released under free and open-source licenses, unless they are marketed or used as
high-risk AI systems or fall under
Article 5 or 50.
Article 3 Definitions:
1. An '
AI system' is a machine-based system designed to operate with different levels of autonomy. It can adapt after being deployed and generates outputs like predictions, content, recommendations, or decisions based on the input it receives, which can affect physical or virtual environments.
2. 'Risk' refers to the likelihood of harm occurring and the seriousness of that harm.
3. A '
provider' is any individual or organization that develops an
AI system or
general-purpose AI model, or has one developed, and markets or uses it under their name or trademark, whether for payment or free.
4. A '
deployer' is any individual or organization using an
AI system under their authority, except for personal non-professional use.
5. An 'authorized representative' is an individual or organization based in the
Union that has received a written
mandate from a
provider to fulfill the
obligations and procedures set by this
Regulation on their behalf.
6. An '
importer' is an individual or organization based in the
Union that markets an
AI system under the name or trademark of a person or organization from a
third country.
12.
This Regulation does not apply to AI systems released under free and open-source licences, unless they are placed on
the market or put into service as high-risk AI systems or as an AI system that falls under Article 5 or 50.
Article 3
Definitions
For the purposes of this Regulation, the following definitions apply:
(1)
‘AI system’ means a machine-based system that is designed to operate with varying levels of autonomy and that may
exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives,
how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or
virtual environments;
(2)
‘risk’ means the combination of the probability of an occurrence of harm and the severity of that harm;
(3)
‘provider’ means a natural or legal person, public authority, agency or other body that develops an AI system or
a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the
market or puts the AI system into service under its own name or trademark, whether for payment or free of charge;
(4)
‘deployer’ means a natural or legal person, public authority, agency or other body using an AI system under its
authority except where the AI system is used in the course of a personal non-professional activity;
(5)
‘authorised representative’ means a natural or legal person located or established in the Union who has received and
accepted a written mandate from a provider of an AI system or a general-purpose AI model to, respectively, perform
and carry out on its behalf the obligations and procedures established by this Regulation;
(6)
‘importer’ means a natural or legal person located or established in the Union that places on the market an AI system
that bears the name or trademark of a natural or legal person established in a third country;
(7)
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(6) An '
importer' is a person or company based in the
Union that sells an
AI system under the name or trademark of a person or company from a non-EU country. (7) A '
distributor' is a person or company in the supply chain, other than the
provider or
importer, that makes an
AI system available for sale in the
Union market. (8) An '
operator' includes the
provider, manufacturer,
deployer, authorized representative,
importer, or
distributor of an
AI system. (9) 'Placing on the market' refers to the first time an
AI system or
general-purpose AI model is made available in the
Union market. (10) 'Making available on the market' means supplying an
AI system or
general-purpose AI model for distribution or use in the
Union market, whether for payment or free. (11) 'Putting into service' means supplying an
AI system for its first use, either directly to the
deployer or for personal use in the
Union. (12) 'Intended purpose' is the use that the
provider specifies for the
AI system, including the context and conditions of use, as detailed in the
provider's instructions, promotional materials, and
technical documentation. (13) 'Reasonably foreseeable misuse' refers to using an
AI system in a way that is not intended but could happen due to predictable human behavior or interaction with other systems, including other
AI systems. (14) A 'safety component' is a part of a product or
AI system that contributes to its safety.
;
(6)
‘importer’ means a natural or legal person located or established in the Union that places on the market an AI system
that bears the name or trademark of a natural or legal person established in a third country;
(7)
‘distributor’ means a natural or legal person in the supply chain, other than the provider or the importer, that makes
an AI system available on the Union market;
(8)
‘operator’ means a provider, product manufacturer, deployer, authorised representative, importer or distributor;
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(9)
‘placing on the market’ means the first making available of an AI system or a general-purpose AI model on the Union
market;
(10) ‘making available on the market’ means the supply of an AI system or a general-purpose AI model for distribution or
use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
(11) ‘putting into service’ means the supply of an AI system for first use directly to the deployer or for own use in the Union
for its intended purpose;
(12) ‘intended purpose’ means the use for which an AI system is intended by the provider, including the specific context
and conditions of use, as specified in the information supplied by the provider in the instructions for use, promotional
or sales materials and statements, as well as in the technical documentation;
(13) ‘reasonably foreseeable misuse’ means the use of an AI system in a way that is not in accordance with its intended
purpose, but which may result from reasonably foreseeable human behaviour or interaction with other systems,
including other AI systems;
(14) ‘safety component’ means a component of a product or of an AI system which fulf
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accordance with its intended
purpose, but which may result from reasonably foreseeable human behaviour or interaction with other systems,
including other AI systems;
(14) ‘safety component’ means a component of a product or of an AI system which fulfils a safety function for that product
or AI system, or the failure or malfunctioning of which endangers the health and safety of persons or property;
(15) ‘instructions for use’ means the information provided by the provider to inform the deployer of, in particular, an AI
system’s intended purpose and proper use;
(16) ‘recall of an AI system’ means any measure aiming to achieve the return to the provider or taking out of service or
disabling the use of an AI system made available to deployers;
(17) ‘withdrawal of an AI system’ means any measure aiming to prevent an AI system in the supply chain being made
available on the market;
(18) ‘performance of an AI system’ means the ability of an AI system to achieve its intended purpose;
(19) ‘notifying authority’ means the national authority responsible for setting up and carrying out the necessary procedures
for the assessment, designation and notification of conformity assessment bodies and for their monitoring;
(20) ‘conformity assessment’ means the process of demonstrating whether the requirements set out in Chapter III, Section 2
relating to a high-risk AI system have been fulfilled;
(21) ‘conformity assessment body’ means a body that performs third-party conformity assessment activities, including
testing, certification and inspection;
(22) ‘notified body’ means a conformity assessment body notified in accordance with this Regulation and other relevant
Union harmonisation legislation;
(23) ‘substantial modification’ means a change to an AI system after its placing on the market or putting into service which
is not foreseen or planned in the initial conformity assessment carried out by the provider and as a result of which the
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23) ‘substantial modification’ means a change to an AI system after its placing on the market or putting into service which
is not foreseen or planned in the initial conformity assessment carried out by the provider and as a result of which the
compliance of the AI system with the requirements set out in Chapter III, Section 2 is affected or results in
a modification to the intended purpose for which the AI system has been assessed;
(24) ‘CE marking’ means a marking by which a provider indicates that an AI system is in conformity with the requirements
set out in Chapter III, Section 2 and other applicable Union harmonisation legislation providing for its affixing;
(25) ‘post-market monitoring system’ means all activities carried out by providers of AI systems to collect and review
experience gained from the use of AI systems they place on the market or put into service for the purpose of
identifying any need to immediately apply any necessary corrective or preventive actions;
(26) ‘market surveillance authority’ means the national authority carrying out the activities and taking the measures
pursuant to Regulation (EU) 2019/1020;
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(27) ‘harmonised standard’ means a harmonised standard as defined in Article 2(1), point (c), of Regulation (EU)
No 1025/2012;
(28) ‘common specification’ means a set of technical specifications as defined in Article 2, point (4) of Regulation (EU)
No 1025/2012, providing means to comply with certain requirements established under this Regulation;
(29) ‘training data’ means data used for training an AI system through fitting its learnable parameters;
(30) ‘validation data’ means data used for providing an evaluation
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This text defines several terms related to
AI systems:
- **
Training data**:
Data used to train an
AI system by adjusting its learnable
parameters.
- **
Validation data**:
Data used to evaluate the trained
AI system and adjust its non-learnable
parameters to avoid underfitting or overfitting.
- **
Validation data set**: A separate set of
data or a portion of the
training data, which can be fixed or variable.
- **Testing
data**:
Data used to independently evaluate the
AI system's performance before it is released or put into use.
- **Input
data**:
Data given to the
AI system that it uses to generate an output.
- **
Biometric data**:
Personal data derived from specific technical processing related to a person's physical, physiological, or behavioral traits, such as facial images or
fingerprints.
- **Biometric identification**: The automated recognition of human features to establish a person's identity by comparing their
biometric data to
data stored in a database.
- **Biometric verification**: The automated process of confirming a person's identity by comparing their
biometric data to previously provided
data.
- **Special categories of
personal data**: Categories defined in specific EU regulations that include sensitive information.
- **Sensitive operational**: (The text cuts off here, but it likely refers to operational
data that is sensitive in nature.)
2, providing means to comply with certain requirements established under this Regulation;
(29) ‘training data’ means data used for training an AI system through fitting its learnable parameters;
(30) ‘validation data’ means data used for providing an evaluation of the trained AI system and for tuning its non-learnable
parameters and its learning process in order, inter alia, to prevent underfitting or overfitting;
(31) ‘validation data set’ means a separate data set or part of the training data set, either as a fixed or variable split;
(32) ‘testing data’ means data used for providing an independent evaluation of the AI system in order to confirm the
expected performance of that system before its placing on the market or putting into service;
(33) ‘input data’ means data provided to or directly acquired by an AI system on the basis of which the system produces an
output;
(34) ‘biometric data’ means personal data resulting from specific technical processing relating to the physical, physiological
or behavioural characteristics of a natural person, such as facial images or dactyloscopic data;
(35) ‘biometric identification’ means the automated recognition of physical, physiological, behavioural, or psychological
human features for the purpose of establishing the identity of a natural person by comparing biometric data of that
individual to biometric data of individuals stored in a database;
(36) ‘biometric verification’ means the automated, one-to-one verification, including authentication, of the identity of
natural persons by comparing their biometric data to previously provided biometric data;
(37) ‘special categories of personal data’ means the categories of personal data referred to in Article 9(1) of Regulation (EU)
2016/679, Article 10 of Directive (EU) 2016/680 and Article 10(1) of Regulation (EU) 2018/1725;
(38) ‘sensitive operational
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According to
Regulation (EU) 2016/679,
Article 10 of Directive (EU) 2016/680, and
Article 10(1) of
Regulation (EU) 2018/1725:
1. '
Sensitive operational data' refers to information related to preventing, detecting, investigating, or prosecuting crimes, which, if disclosed, could harm the integrity of criminal proceedings.
2. An '
emotion recognition system' is an
AI tool designed to identify or infer people's emotions or intentions based on their
biometric data.
3. A '
biometric categorisation system' is an
AI tool that assigns individuals to specific categories based on their
biometric data, unless it is part of another commercial service and necessary for technical reasons.
4. A '
remote biometric identification system' is an
AI tool that identifies individuals without their active participation, usually from a distance, by comparing their
biometric data to a reference database.
5. A '
real-time remote biometric identification system' is a type of remote system where the capturing, comparing, and identifying of
biometric data happens almost instantly, with only minimal delays to prevent evasion.
6. A '
post-remote biometric identification system' is any remote identification system that is not real-time.
7. A '
publicly accessible space' is any physical location, whether public or private, that can be accessed by an unspecified number of people, regardless of any access conditions or capacity limits.
of Regulation (EU)
2016/679, Article 10 of Directive (EU) 2016/680 and Article 10(1) of Regulation (EU) 2018/1725;
(38) ‘sensitive operational data’ means operational data related to activities of prevention, detection, investigation or
prosecution of criminal offences, the disclosure of which could jeopardise the integrity of criminal proceedings;
(39) ‘emotion recognition system’ means an AI system for the purpose of identifying or inferring emotions or intentions of
natural persons on the basis of their biometric data;
(40) ‘biometric categorisation system’ means an AI system for the purpose of assigning natural persons to specific
categories on the basis of their biometric data, unless it is ancillary to another commercial service and strictly
necessary for objective technical reasons;
(41) ‘remote biometric identification system’ means an AI system for the purpose of identifying natural persons, without
their active involvement, typically at a distance through the comparison of a person’s biometric data with the
biometric data contained in a reference database;
(42) ‘real-time remote biometric identification system’ means a remote biometric identification system, whereby the
capturing of biometric data, the comparison and the identification all occur without a significant delay, comprising
not only instant identification, but also limited short delays in order to avoid circumvention;
(43) ‘post-remote biometric identification system’ means a remote biometric identification system other than a real-time
remote biometric identification system;
(44) ‘publicly accessible space’ means any publicly or privately owned physical place accessible to an undetermined number
of natural persons, regardless of whether certain conditions for access may apply, and regardless of the potential
capacity restrictions;
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A 'place' refers to any physical location, whether publicly or privately owned, that can be accessed by an unspecified number of people, regardless of any access conditions or capacity limits.
(45) A '
law enforcement authority' is defined as:
(a) any public authority responsible for preventing, investigating, detecting, or prosecuting criminal offenses, as well as enforcing criminal penalties and ensuring
public security; or
(b) any other organization designated by
national law to perform these public functions related to crime prevention and public safety.
(46) '
Law enforcement' includes activities conducted by
law enforcement authorities or on their behalf to prevent, investigate, detect, or prosecute criminal offenses and enforce penalties, while also ensuring public safety.
(47) The '
AI Office' refers to the
Commission's role in overseeing the implementation, monitoring, and governance of
AI systems and
general-purpose AI models, as established in the
Commission Decision of January 24, 2024. References to the
AI Office in this
regulation should be understood as references to the
Commission.
(48) A '
national competent authority' is either a
notifying authority or a
market surveillance authority. For
AI systems used by EU institutions, agencies, and bodies, references to
national authorities in this
regulation should be interpreted as referring to the
European Data Protection Supervisor.
(49) A '
serious incident' is defined as an event or malfunction of an
AI system that results in direct or indirect consequences.
’ means any publicly or privately owned physical place accessible to an undetermined number
of natural persons, regardless of whether certain conditions for access may apply, and regardless of the potential
capacity restrictions;
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(45) ‘law enforcement authority’ means:
(a) any public authority competent for the prevention, investigation, detection or prosecution of criminal offences or
the execution of criminal penalties, including the safeguarding against and the prevention of threats to public
security; or
(b) any other body or entity entrusted by Member State law to exercise public authority and public powers for the
purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of
criminal penalties, including the safeguarding against and the prevention of threats to public security;
(46) ‘law enforcement’ means activities carried out by law enforcement authorities or on their behalf for the prevention,
investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including
safeguarding against and preventing threats to public security;
(47) ‘AI Office’ means the Commission’s function of contributing to the implementation, monitoring and supervision of AI
systems and general-purpose AI models, and AI governance, provided for in Commission Decision of 24 January
2024; references in this Regulation to the AI Office shall be construed as references to the Commission;
(48) ‘national competent authority’ means a notifying authority or a market surveillance authority; as regards AI systems
put into service or used by Union institutions, agencies, offices and bodies, references to national competent
authorities or market surveillance authorities in this Regulation shall be construed as references to the European Data
Protection Supervisor;
(49) ‘serious incident’ means an incident or malfunctioning of an AI system that directly or indirectly leads to any of the
Show original text
In this
regulation, references to authorities or
market surveillance authorities mean the
European Data Protection Supervisor. A '
serious incident' refers to a malfunction of an
AI system that results in: (a) the death of a person or serious health harm; (b) major disruption to
critical infrastructure; (c) violations of
Union laws protecting
fundamental rights; or (d) significant damage to property or the environment. '
Personal data' is defined in
Article 4, point (1) of
Regulation (EU) 2016/679, while 'non-
personal data' refers to any
data that is not
personal data as defined in the same article. 'Profiling' is also defined in
Article 4, point (4) of
Regulation (EU) 2016/679. A '
real-world testing plan' is a document outlining the goals, methods, geographical area, population, timing, monitoring, organization, and execution of tests in real-world settings. A '
sandbox plan' is an agreement between a
provider and a
competent authority that details the objectives, conditions, timeline, methods, and requirements for activities within a
sandbox. An '
AI regulatory sandbox' is a controlled environment established by a
competent authority that allows
AI system providers to develop, train, validate, and test
innovative AI systems under regulatory supervision for a limited time, following a
sandbox plan. '
AI literacy' refers to the skills, knowledge, and understanding that enable
providers,
users, and affected individuals to make informed decisions based on their rights and responsibilities under this
regulation.
authorities or market surveillance authorities in this Regulation shall be construed as references to the European Data
Protection Supervisor;
(49) ‘serious incident’ means an incident or malfunctioning of an AI system that directly or indirectly leads to any of the
following:
(a) the death of a person, or serious harm to a person’s health;
(b) a serious and irreversible disruption of the management or operation of critical infrastructure;
(c) the infringement of obligations under Union law intended to protect fundamental rights;
(d) serious harm to property or the environment;
(50) ‘personal data’ means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679;
(51) ‘non-personal data’ means data other than personal data as defined in Article 4, point (1), of Regulation (EU)
2016/679;
(52) ‘profiling’ means profiling as defined in Article 4, point (4), of Regulation (EU) 2016/679;
(53) ‘real-world testing plan’ means a document that describes the objectives, methodology, geographical, population and
temporal scope, monitoring, organisation and conduct of testing in real-world conditions;
(54) ‘sandbox plan’ means a document agreed between the participating provider and the competent authority describing
the objectives, conditions, timeframe, methodology and requirements for the activities carried out within the sandbox;
(55) ‘AI regulatory sandbox’ means a controlled framework set up by a competent authority which offers providers or
prospective providers of AI systems the possibility to develop, train, validate and test, where appropriate in real-world
conditions, an innovative AI system, pursuant to a sandbox plan for a limited time under regulatory supervision;
(56) ‘AI literacy’ means skills, knowledge and understanding that allow providers, deployers and affected persons, taking
into account their respective rights and obligations in the context of this Regulation, to make an informed
Show original text
The following terms are defined under regulatory supervision for a limited time:
1. **
AI Literacy**: This refers to the skills, knowledge, and understanding that help
providers,
users, and affected individuals to effectively use
AI systems. It includes awareness of the benefits and risks of
AI, as well as potential harm.
2. **
Testing in Real-World Conditions**: This is the temporary testing of an
AI system in actual environments (not in labs) to collect reliable
data and check if the
AI meets regulatory standards. This testing does not count as officially launching the
AI system, as long as it meets the conditions in Articles 57 or 60.
3. **
Subject**: In the context of real-world testing, a
subject is a person who takes part in the testing.
4. **
Informed Consent**: This is when a
subject voluntarily agrees to participate in testing after being fully informed about all relevant aspects of the testing.
5. **
Deep Fake**: This refers to
AI-created or altered images, audio, or videos that mimic real people, objects, or events, making them appear authentic or truthful when they are not.
6. **
Widespread Infringement**: This means any action or failure to act that goes against EU laws protecting individual rights, which has harmed or could harm the collective interests of individuals living in the EU.
a limited time under regulatory supervision;
(56) ‘AI literacy’ means skills, knowledge and understanding that allow providers, deployers and affected persons, taking
into account their respective rights and obligations in the context of this Regulation, to make an informed deployment
of AI systems, as well as to gain awareness about the opportunities and risks of AI and possible harm it can cause;
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(57) ‘testing in real-world conditions’ means the temporary testing of an AI system for its intended purpose in real-world
conditions outside a laboratory or otherwise simulated environment, with a view to gathering reliable and robust data
and to assessing and verifying the conformity of the AI system with the requirements of this Regulation and it does
not qualify as placing the AI system on the market or putting it into service within the meaning of this Regulation,
provided that all the conditions laid down in Article 57 or 60 are fulfilled;
(58) ‘subject’, for the purpose of real-world testing, means a natural person who participates in testing in real-world
conditions;
(59) ‘informed consent’ means a subject’s freely given, specific, unambiguous and voluntary expression of his or her
willingness to participate in a particular testing in real-world conditions, after having been informed of all aspects of
the testing that are relevant to the subject’s decision to participate;
(60) ‘deep fake’ means AI-generated or manipulated image, audio or video content that resembles existing persons, objects,
places, entities or events and would falsely appear to a person to be authentic or truthful;
(61) ‘widespread infringement’ means any act or omission contrary to Union law protecting the interest of individuals,
which:
(a) has harmed or is likely to harm the collective interests of individuals residing in at
Show original text
To be authentic or truthful; (61) '
widespread infringement' refers to any action or failure to act that goes against
Union law meant to protect individuals' interests. This includes: (a) actions that have harmed or could harm the collective interests of individuals living in at least two
Member States, excluding the
Member State where the action occurred or where the
provider or
deployer is based; (b) actions that have caused or could cause harm to collective interests and share common characteristics, such as the same illegal practice, occurring simultaneously by the same
operator in at least three
Member States; (62) '
critical infrastructure' is defined in Article 2, point (4), of
Directive (EU) 2022/2557; (63) '
general-purpose AI model' is an
AI model that is trained on a large dataset using
self-supervision and can perform a wide range of tasks, regardless of how it is marketed, excluding models used for research or development before being sold; (64) '
high-impact capabilities' are those that match or exceed the abilities of the most advanced
general-purpose AI models; (65) '
systemic risk' refers to risks specific to the
high-impact capabilities of
general-purpose AI models that could significantly affect the
Union market or have negative consequences for public health, safety, security, or
fundamental rights.
to be authentic or truthful;
(61) ‘widespread infringement’ means any act or omission contrary to Union law protecting the interest of individuals,
which:
(a) has harmed or is likely to harm the collective interests of individuals residing in at least two Member States other
than the Member State in which:
(i) the act or omission originated or took place;
(ii) the provider concerned, or, where applicable, its authorised representative is located or established; or
(iii) the deployer is established, when the infringement is committed by the deployer;
(b) has caused, causes or is likely to cause harm to the collective interests of individuals and has common features,
including the same unlawful practice or the same interest being infringed, and is occurring concurrently,
committed by the same operator, in at least three Member States;
(62) ‘critical infrastructure’ means critical infrastructure as defined in Article 2, point (4), of Directive (EU) 2022/2557;
(63) ‘general-purpose AI model’ means an AI model, including where such an AI model is trained with a large amount of
data using self-supervision at scale, that displays significant generality and is capable of competently performing
a wide range of distinct tasks regardless of the way the model is placed on the market and that can be integrated into
a variety of downstream systems or applications, except AI models that are used for research, development or
prototyping activities before they are placed on the market;
(64) ‘high-impact capabilities’ means capabilities that match or exceed the capabilities recorded in the most advanced
general-purpose AI models;
(65) ‘systemic risk’ means a risk that is specific to the high-impact capabilities of general-purpose AI models, having
a significant impact on the Union market due to their reach, or due to actual or reasonably foreseeable negative effects
on public health, safety, public security, fundamental rights, or the
Show original text
General-purpose AI models can significantly affect the market and may have negative impacts on public health, safety, security,
fundamental rights, or society as a whole, especially when these effects can spread widely across the value chain. A '
general-purpose AI system' is defined as an
AI system that uses a
general-purpose AI model and can be used for various purposes, either directly or by being integrated into other
AI systems. A 'floating-point operation' refers to any mathematical operation involving floating-point numbers, which are a type of real number represented in computers using a fixed precision integer scaled by a fixed base integer exponent. A '
downstream provider' is any
provider of an
AI system, including
general-purpose AI systems, that integrates an
AI model, regardless of whether they created the model themselves or obtained it through contracts with another entity.
Article 4 discusses
AI literacy, stating that
providers and
users of
AI systems must ensure their staff and others involved in operating and using these systems have adequate
AI knowledge. This should consider their technical skills, experience, education, and the specific context in which the
AI systems will be used, as well as the individuals or groups affected by these systems.
Chapter II outlines
prohibited AI practices in
Article 5.
to the high-impact capabilities of general-purpose AI models, having
a significant impact on the Union market due to their reach, or due to actual or reasonably foreseeable negative effects
on public health, safety, public security, fundamental rights, or the society as a whole, that can be propagated at scale
across the value chain;
(66) ‘general-purpose AI system’ means an AI system which is based on a general-purpose AI model and which has the
capability to serve a variety of purposes, both for direct use as well as for integration in other AI systems;
(67) ‘floating-point operation’ means any mathematical operation or assignment involving floating-point numbers, which
are a subset of the real numbers typically represented on computers by an integer of fixed precision scaled by an
integer exponent of a fixed base;
(68) ‘downstream provider’ means a provider of an AI system, including a general-purpose AI system, which integrates an
AI model, regardless of whether the AI model is provided by themselves and vertically integrated or provided by
another entity based on contractual relations.
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Article 4
AI literacy
Providers and deployers of AI systems shall take measures to ensure, to their best extent, a sufficient level of AI literacy of
their staff and other persons dealing with the operation and use of AI systems on their behalf, taking into account their
technical knowledge, experience, education and training and the context the AI systems are to be used in, and considering
the persons or groups of persons on whom the AI systems are to be used.
CHAPTER II
PROHIBITED AI PRACTICES
Article 5
Prohibited AI practices
1.
Show original text
AI systems must be used with consideration for the individuals or groups they affect.
**CHAPTER II:
PROHIBITED AI PRACTICES**
**
Article 5:
Prohibited AI Practices**
1. The following
AI practices are not allowed:
(a) Selling, using, or implementing an
AI system that uses subliminal techniques or manipulative methods to significantly distort a person's or group's behavior, impairing their ability to make informed decisions and potentially causing them
significant harm.
(b) Selling, using, or implementing an
AI system that takes advantage of the vulnerabilities of individuals or specific groups due to their age, disability, or particular social or economic situations, leading to harmful behavior changes.
(c) Selling, using, or implementing
AI systems that evaluate or classify individuals or groups over time based on their social behavior or personal characteristics, resulting in:
(i) Unfair treatment of individuals or groups in unrelated social contexts;
(ii) Unjustified negative treatment of individuals or groups.
AI systems are to be used in, and considering
the persons or groups of persons on whom the AI systems are to be used.
CHAPTER II
PROHIBITED AI PRACTICES
Article 5
Prohibited AI practices
1.
The following AI practices shall be prohibited:
(a) the placing on the market, the putting into service or the use of an AI system that deploys subliminal techniques beyond
a person’s consciousness or purposefully manipulative or deceptive techniques, with the objective, or the effect of
materially distorting the behaviour of a person or a group of persons by appreciably impairing their ability to make an
informed decision, thereby causing them to take a decision that they would not have otherwise taken in a manner that
causes or is reasonably likely to cause that person, another person or group of persons significant harm;
(b) the placing on the market, the putting into service or the use of an AI system that exploits any of the vulnerabilities of
a natural person or a specific group of persons due to their age, disability or a specific social or economic situation, with
the objective, or the effect, of materially distorting the behaviour of that person or a person belonging to that group in
a manner that causes or is reasonably likely to cause that person or another person significant harm;
(c) the placing on the market, the putting into service or the use of AI systems for the evaluation or classification of natural
persons or groups of persons over a certain period of time based on their social behaviour or known, inferred or
predicted personal or personality characteristics, with the social score leading to either or both of the following:
(i) detrimental or unfavourable treatment of certain natural persons or groups of persons in social contexts that are
unrelated to the contexts in which the data was originally generated or collected;
(ii) detrimental or unfavourable treatment of certain natural persons or groups of persons that is unjustified or
dispro
Show original text
This text outlines several prohibitions related to the use of
AI systems: (i) Using
data about individuals or groups in social situations that are not connected to where the
data was originally collected; (ii) Treating certain individuals or groups unfairly without justification, especially if the treatment is excessive compared to their behavior; (d) Selling or using
AI systems to assess the risk of someone committing a crime based only on their profile or personality traits, unless the
AI supports human judgment based on clear evidence of criminal activity; (e) Selling or using
AI systems that gather facial images from the internet or CCTV without targeting specific individuals to create or enhance
facial recognition databases; (f) Selling or using
AI systems to determine people's emotions in workplaces or educational settings, unless it's for medical or safety purposes; (g) Selling or using biometric categorization systems that classify individuals based on their
biometric data to infer sensitive information like race, political beliefs,
union membership, religious beliefs, sexual orientation, or personal relationships.
persons or groups of persons in social contexts that are
unrelated to the contexts in which the data was originally generated or collected;
(ii) detrimental or unfavourable treatment of certain natural persons or groups of persons that is unjustified or
disproportionate to their social behaviour or its gravity;
(d) the placing on the market, the putting into service for this specific purpose, or the use of an AI system for making risk
assessments of natural persons in order to assess or predict the risk of a natural person committing a criminal offence,
based solely on the profiling of a natural person or on assessing their personality traits and characteristics; this
prohibition shall not apply to AI systems used to support the human assessment of the involvement of a person in
a criminal activity, which is already based on objective and verifiable facts directly linked to a criminal activity;
(e) the placing on the market, the putting into service for this specific purpose, or the use of AI systems that create or
expand facial recognition databases through the untargeted scraping of facial images from the internet or CCTV footage;
(f) the placing on the market, the putting into service for this specific purpose, or the use of AI systems to infer emotions
of a natural person in the areas of workplace and education institutions, except where the use of the AI system is
intended to be put in place or into the market for medical or safety reasons;
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(g) the placing on the market, the putting into service for this specific purpose, or the use of biometric categorisation
systems that categorise individually natural persons based on their biometric data to deduce or infer their race, political
opinions, trade union membership, religious or philosophical beliefs, sex life or sexual orientation; this prohibition does
not
Show original text
Biometric categorization systems analyze individuals'
biometric data to determine their race, political views,
union membership, religious beliefs, sexual orientation, or personal relationships. However, this prohibition does not apply to the lawful labeling or filtering of biometric datasets, like images, or to the categorization of
biometric data for
law enforcement purposes.
Additionally, the use of
real-time remote biometric identification systems in public spaces for
law enforcement is restricted. Such use is only allowed when it is essential for:
1. Searching for specific victims of abduction, human trafficking, or sexual exploitation, as well as locating missing persons;
2. Preventing a serious and immediate threat to someone's life or safety, or a credible threat of a terrorist attack;
3. Identifying or locating a person suspected of a crime, to aid in criminal investigations or prosecutions for serious offenses that could lead to imprisonment for at least four years.
This
regulation does not affect
Article 9 of
Regulation (EU) 2016/679, which governs the processing of
biometric data for non-
law enforcement purposes.
ometric categorisation
systems that categorise individually natural persons based on their biometric data to deduce or infer their race, political
opinions, trade union membership, religious or philosophical beliefs, sex life or sexual orientation; this prohibition does
not cover any labelling or filtering of lawfully acquired biometric datasets, such as images, based on biometric data or
categorizing of biometric data in the area of law enforcement;
(h) the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purposes of law
enforcement, unless and in so far as such use is strictly necessary for one of the following objectives:
(i) the targeted search for specific victims of abduction, trafficking in human beings or sexual exploitation of human
beings, as well as the search for missing persons;
(ii) the prevention of a specific, substantial and imminent threat to the life or physical safety of natural persons or
a genuine and present or genuine and foreseeable threat of a terrorist attack;
(iii) the localisation or identification of a person suspected of having committed a criminal offence, for the purpose of
conducting a criminal investigation or prosecution or executing a criminal penalty for offences referred to in
Annex II and punishable in the Member State concerned by a custodial sentence or a detention order for
a maximum period of at least four years.
Point (h) of the first subparagraph is without prejudice to Article 9 of Regulation (EU) 2016/679 for the processing of
biometric data for purposes other than law enforcement.
2.
Show original text
The maximum duration for using
remote biometric identification systems for
law enforcement purposes is at least four years. This use must comply with
Article 9 of
Regulation (EU) 2016/679, which governs the processing of
biometric data for non-
law enforcement purposes.
When using 'real-time'
remote biometric identification in public spaces for
law enforcement, it should only be used to confirm the identity of a specific individual. The decision to use these systems must consider:
(a) the seriousness, likelihood, and extent of harm that could occur if the system is not used;
(b) the impact of using the system on the rights and freedoms of all individuals involved, particularly the seriousness, likelihood, and extent of those impacts.
Additionally, the use of these systems must follow necessary and proportionate
safeguards according to
national law, including limits on time, location, and individuals involved.
Law enforcement must conduct a
fundamental rights impact assessment as outlined in
Article 27 and register the system in the
EU database as per
Article 49. However, in
urgent situations, these systems can be used without prior registration, as long as the registration is completed promptly.
maximum period of at least four years.
Point (h) of the first subparagraph is without prejudice to Article 9 of Regulation (EU) 2016/679 for the processing of
biometric data for purposes other than law enforcement.
2.
The use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purposes of law
enforcement for any of the objectives referred to in paragraph 1, first subparagraph, point (h), shall be deployed for the
purposes set out in that point only to confirm the identity of the specifically targeted individual, and it shall take into
account the following elements:
(a) the nature of the situation giving rise to the possible use, in particular the seriousness, probability and scale of the harm
that would be caused if the system were not used;
(b) the consequences of the use of the system for the rights and freedoms of all persons concerned, in particular the
seriousness, probability and scale of those consequences.
In addition, the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purposes of
law enforcement for any of the objectives referred to in paragraph 1, first subparagraph, point (h), of this Article shall
comply with necessary and proportionate safeguards and conditions in relation to the use in accordance with the national
law authorising the use thereof, in particular as regards the temporal, geographic and personal limitations. The use of the
‘real-time’ remote biometric identification system in publicly accessible spaces shall be authorised only if the law
enforcement authority has completed a fundamental rights impact assessment as provided for in Article 27 and has
registered the system in the EU database according to Article 49. However, in duly justified cases of urgency, the use of such
systems may be commenced without the registration in the EU database, provided that such registration is completed
without undue delay.
3.
Show original text
In the EU, systems for
remote biometric identification must be registered in the
EU database as per
Article 49. However, in
urgent situations, these systems can be used without prior registration, as long as the registration is completed quickly. For
law enforcement purposes, using a 'real-time'
remote biometric identification system in public spaces requires prior approval from a judicial or
independent administrative authority in the relevant
Member State. This approval must be based on a justified request and follow national laws. In urgent cases, the system can be used without prior approval, but the request for authorization must be made within 24 hours. If the authorization is denied, the use of the system must stop immediately, and all
data and results must be deleted. The authority will only grant approval if it is convinced, based on clear evidence, that using the system is necessary and proportionate to achieve specific objectives, and that the use is limited in time, location, and personal scope.
system in the EU database according to Article 49. However, in duly justified cases of urgency, the use of such
systems may be commenced without the registration in the EU database, provided that such registration is completed
without undue delay.
3.
For the purposes of paragraph 1, first subparagraph, point (h) and paragraph 2, each use for the purposes of law
enforcement of a ‘real-time’ remote biometric identification system in publicly accessible spaces shall be subject to a prior
authorisation granted by a judicial authority or an independent administrative authority whose decision is binding of the
Member State in which the use is to take place, issued upon a reasoned request and in accordance with the detailed rules of
national law referred to in paragraph 5. However, in a duly justified situation of urgency, the use of such system may be
commenced without an authorisation provided that such authorisation is requested without undue delay, at the latest
within 24 hours. If such authorisation is rejected, the use shall be stopped with immediate effect and all the data, as well as
the results and outputs of that use shall be immediately discarded and deleted.
The competent judicial authority or an independent administrative authority whose decision is binding shall grant the
authorisation only where it is satisfied, on the basis of objective evidence or clear indications presented to it, that the use of
the ‘real-time’ remote biometric identification system concerned is necessary for, and proportionate to, achieving one of the
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objectives specified in paragraph 1, first subparagraph, point (h), as identified in the request and, in particular, remains
limited to what is strictly necessary concerning the period of time as well as the geographic and personal scope.
Show original text
The objectives mentioned in paragraph 1, first subparagraph, point (h) must be strictly followed, focusing only on what is necessary regarding time, location, and individuals involved. When making a decision on the request, the authority must consider the factors listed in paragraph 2. No decision that negatively affects a person can be made solely based on the results from the 'real-time'
remote biometric identification system.
Additionally, every use of this system in public spaces for
law enforcement must be reported to the relevant
market surveillance authority and the
national data protection authority, following national rules outlined in
paragraph 5. This notification must include the information specified in paragraph 6 but should not contain sensitive operational details.
A
Member State can choose to allow the use of 'real-time'
remote biometric identification systems in public spaces for
law enforcement, as long as it adheres to the limits and conditions stated in paragraph 1, first subparagraph, point (h), and paragraphs 2 and 3. Each
Member State must establish detailed national laws regarding the request, issuance, use, supervision, and reporting of these authorizations. These laws should also clarify which objectives from paragraph 1, first subparagraph, point (h), including specific criminal offenses mentioned in point (h)(iii), allow authorities to use these systems for
law enforcement.
Member States must inform the
Commission of these rules within 30 days of their adoption.
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objectives specified in paragraph 1, first subparagraph, point (h), as identified in the request and, in particular, remains
limited to what is strictly necessary concerning the period of time as well as the geographic and personal scope. In deciding
on the request, that authority shall take into account the elements referred to in paragraph 2. No decision that produces an
adverse legal effect on a person may be taken based solely on the output of the ‘real-time’ remote biometric identification
system.
4.
Without prejudice to paragraph 3, each use of a ‘real-time’ remote biometric identification system in publicly
accessible spaces for law enforcement purposes shall be notified to the relevant market surveillance authority and the
national data protection authority in accordance with the national rules referred to in paragraph 5. The notification shall, as
a minimum, contain the information specified under paragraph 6 and shall not include sensitive operational data.
5.
A Member State may decide to provide for the possibility to fully or partially authorise the use of ‘real-time’ remote
biometric identification systems in publicly accessible spaces for the purposes of law enforcement within the limits and
under the conditions listed in paragraph 1, first subparagraph, point (h), and paragraphs 2 and 3. Member States concerned
shall lay down in their national law the necessary detailed rules for the request, issuance and exercise of, as well as
supervision and reporting relating to, the authorisations referred to in paragraph 3. Those rules shall also specify in respect
of which of the objectives listed in paragraph 1, first subparagraph, point (h), including which of the criminal offences
referred to in point (h)(iii) thereof, the competent authorities may be authorised to use those systems for the purposes of
law enforcement. Member States shall notify those rules to the Commission at the latest 30 days following the adoption
thereof.
Show original text
to in point (h)(iii) thereof, the competent authorities may be authorised to use those systems for the purposes of
law enforcement. Member States shall notify those rules to the Commission at the latest 30 days following the adoption
thereof. Member States may introduce, in accordance with Union law, more restrictive laws on the use of remote biometric
identification systems.
6.
National market surveillance authorities and the national data protection authorities of Member States that have been
notified of the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for law enforcement
purposes pursuant to paragraph 4 shall submit to the Commission annual reports on such use. For that purpose, the
Commission shall provide Member States and national market surveillance and data protection authorities with a template,
including information on the number of the decisions taken by competent judicial authorities or an independent
administrative authority whose decision is binding upon requests for authorisations in accordance with paragraph 3 and
their result.
7.
The Commission shall publish annual reports on the use of real-time remote biometric identification systems in
publicly accessible spaces for law enforcement purposes, based on aggregated data in Member States on the basis of the
annual reports referred to in paragraph 6. Those annual reports shall not include sensitive operational data of the related
law enforcement activities.
8.
This Article shall not affect the prohibitions that apply where an AI practice infringes other Union law.
CHAPTER III
HIGH-RISK AI SYSTEMS
SECTION 1
Classification of AI systems as high-risk
Article 6
Classification rules for high-risk AI systems
1.
Show original text
This section outlines the rules for classifying
high-risk AI systems. An
AI system is considered high-risk if it meets two conditions: (1) it is used as a safety component of a product or is a product itself that falls under specific EU safety regulations listed in
Annex I, and (2) the product, which includes the
AI system, must pass a third-party safety assessment before it can be sold or used, according to the same EU regulations. Additionally, certain
AI systems listed in
Annex III are also classified as high-risk. However, an
AI system from
Annex III will not be considered high-risk if it does not significantly threaten the health, safety, or
fundamental rights of individuals, including if it does not greatly affect decision-making outcomes.
prohibitions that apply where an AI practice infringes other Union law.
CHAPTER III
HIGH-RISK AI SYSTEMS
SECTION 1
Classification of AI systems as high-risk
Article 6
Classification rules for high-risk AI systems
1.
Irrespective of whether an AI system is placed on the market or put into service independently of the products
referred to in points (a) and (b), that AI system shall be considered to be high-risk where both of the following conditions
are fulfilled:
(a) the AI system is intended to be used as a safety component of a product, or the AI system is itself a product, covered by
the Union harmonisation legislation listed in Annex I;
(b) the product whose safety component pursuant to point (a) is the AI system, or the AI system itself as a product, is
required to undergo a third-party conformity assessment, with a view to the placing on the market or the putting into
service of that product pursuant to the Union harmonisation legislation listed in Annex I.
2.
In addition to the high-risk AI systems referred to in paragraph 1, AI systems referred to in Annex III shall be
considered to be high-risk.
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3.
By derogation from paragraph 2, an AI system referred to in Annex III shall not be considered to be high-risk where it
does not pose a significant risk of harm to the health, safety or fundamental rights of natural persons, including by not
materially influencing the outcome of decision making.
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An
AI system mentioned in
Annex III is not considered high-risk if it does not significantly threaten the health, safety, or
fundamental rights of individuals, and does not greatly affect decision-making outcomes. This applies if any of the following conditions are met: (a) the
AI system is designed for a specific, limited task; (b) it aims to enhance the results of a task already completed by a human; (c) it identifies patterns in decision-making without replacing or influencing the human assessment, which must be reviewed by a person; or (d) it prepares information for an assessment related to the use cases in
Annex III. However, any
AI system that profiles individuals is always deemed high-risk.
Providers who believe their
AI system is not high-risk must document their assessment before the system is marketed or used. They must also register as required by
Article 49(2) and provide this documentation to
national authorities if requested. The
Commission will, after consulting the
European Artificial Intelligence Board, issue guidelines by February 2, 2026, detailing how to implement this article and will include examples of high-risk and not
high-risk AI systems.
system referred to in Annex III shall not be considered to be high-risk where it
does not pose a significant risk of harm to the health, safety or fundamental rights of natural persons, including by not
materially influencing the outcome of decision making.
The first subparagraph shall apply where any of the following conditions is fulfilled:
(a) the AI system is intended to perform a narrow procedural task;
(b) the AI system is intended to improve the result of a previously completed human activity;
(c) the AI system is intended to detect decision-making patterns or deviations from prior decision-making patterns and is
not meant to replace or influence the previously completed human assessment, without proper human review; or
(d) the AI system is intended to perform a preparatory task to an assessment relevant for the purposes of the use cases
listed in Annex III.
Notwithstanding the first subparagraph, an AI system referred to in Annex III shall always be considered to be high-risk
where the AI system performs profiling of natural persons.
4.
A provider who considers that an AI system referred to in Annex III is not high-risk shall document its assessment
before that system is placed on the market or put into service. Such provider shall be subject to the registration obligation
set out in Article 49(2). Upon request of national competent authorities, the provider shall provide the documentation of
the assessment.
5.
The Commission shall, after consulting the European Artificial Intelligence Board (the ‘Board’), and no later than
2 February 2026, provide guidelines specifying the practical implementation of this Article in line with Article 96 together
with a comprehensive list of practical examples of use cases of AI systems that are high-risk and not high-risk.
6.
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By February 2, 2026, the
Commission must provide guidelines for implementing this Article, in accordance with
Article 96. These guidelines should include a detailed list of practical examples of both high-risk and low-risk
AI systems.
The
Commission has the authority to make changes to the conditions outlined in paragraph 3, second subparagraph, of this Article through delegated acts, as stated in
Article 97. This can happen if there is solid evidence that certain
AI systems listed in
Annex III do not pose a significant risk to health, safety, or
fundamental rights.
Additionally, the
Commission can remove any conditions in paragraph 3, second subparagraph, if there is reliable evidence showing that such changes are necessary to maintain the protection of health, safety, and
fundamental rights as required by this
Regulation.
Any changes made to the conditions in paragraph 3 must not lower the overall protection of health, safety, and
fundamental rights provided by this
Regulation. These changes should also align with other delegated acts from
Article 7(1) and consider market and technological advancements.
later than
2 February 2026, provide guidelines specifying the practical implementation of this Article in line with Article 96 together
with a comprehensive list of practical examples of use cases of AI systems that are high-risk and not high-risk.
6.
The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend paragraph 3,
second subparagraph, of this Article by adding new conditions to those laid down therein, or by modifying them, where
there is concrete and reliable evidence of the existence of AI systems that fall under the scope of Annex III, but do not pose
a significant risk of harm to the health, safety or fundamental rights of natural persons.
7.
The Commission shall adopt delegated acts in accordance with Article 97 in order to amend paragraph 3, second
subparagraph, of this Article by deleting any of the conditions laid down therein, where there is concrete and reliable
evidence that this is necessary to maintain the level of protection of health, safety and fundamental rights provided for by
this Regulation.
8.
Any amendment to the conditions laid down in paragraph 3, second subparagraph, adopted in accordance with
paragraphs 6 and 7 of this Article shall not decrease the overall level of protection of health, safety and fundamental rights
provided for by this Regulation and shall ensure consistency with the delegated acts adopted pursuant to Article 7(1), and
take account of market and technological developments.
Article 7
Amendments to Annex III
1.
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safety and fundamental rights
provided for by this Regulation and shall ensure consistency with the delegated acts adopted pursuant to Article 7(1), and
take account of market and technological developments.
Article 7
Amendments to Annex III
1.
The Commission is empowered to adopt delegated acts in accordance with Article 97 to amend Annex III by adding
or modifying use-cases of high-risk AI systems where both of the following conditions are fulfilled:
(a) the AI systems are intended to be used in any of the areas listed in Annex III;
(b) the AI systems pose a risk of harm to health and safety, or an adverse impact on fundamental rights, and that risk is
equivalent to, or greater than, the risk of harm or of adverse impact posed by the high-risk AI systems already referred
to in Annex III.
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2.
When assessing the condition under paragraph 1, point (b), the Commission shall take into account the following
criteria:
(a) the intended purpose of the AI system;
(b) the extent to which an AI system has been used or is likely to be used;
(c) the nature and amount of the data processed and used by the AI system, in particular whether special categories of
personal data are processed;
(d) the extent to which the AI system acts autonomously and the possibility for a human to override a decision or
recommendations that may lead to potential harm;
(e) the extent to which the use of an AI system has already caused harm to health and safety, has had an adverse impact on
fundamental rights or has given rise to significant concerns in relation to the likelihood of such harm or adverse impact,
as demonstrated, for example, by reports or documented allegations submitted to national competent authorities or by
other reports, as appropriate
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The impact on
fundamental rights or concerns about potential harm can be shown through reports or allegations made to
national authorities. Key factors to consider include: (f) the potential severity of harm and its ability to affect many people or disproportionately impact specific groups; (g) how dependent individuals are on the outcomes produced by an
AI system, especially if they cannot reasonably opt-out; (h) any power imbalances where those at risk are vulnerable compared to the
AI system's
deployer, due to factors like status, authority, knowledge, economic or social conditions, or age; (i) how easily the outcomes from the
AI system can be corrected or reversed, noting that negative impacts on health, safety, or
fundamental rights are not easily fixable; (j) the potential benefits of the
AI system for individuals, groups, or society, including improvements in product safety; (k) how existing
Union law provides: (i) effective ways to address risks from
AI systems, excluding damage claims; (ii) effective measures to prevent or significantly reduce those risks.
impact on
fundamental rights or has given rise to significant concerns in relation to the likelihood of such harm or adverse impact,
as demonstrated, for example, by reports or documented allegations submitted to national competent authorities or by
other reports, as appropriate;
(f) the potential extent of such harm or such adverse impact, in particular in terms of its intensity and its ability to affect
multiple persons or to disproportionately affect a particular group of persons;
(g) the extent to which persons who are potentially harmed or suffer an adverse impact are dependent on the outcome
produced with an AI system, in particular because for practical or legal reasons it is not reasonably possible to opt-out
from that outcome;
(h) the extent to which there is an imbalance of power, or the persons who are potentially harmed or suffer an adverse
impact are in a vulnerable position in relation to the deployer of an AI system, in particular due to status, authority,
knowledge, economic or social circumstances, or age;
(i) the extent to which the outcome produced involving an AI system is easily corrigible or reversible, taking into account
the technical solutions available to correct or reverse it, whereby outcomes having an adverse impact on health, safety or
fundamental rights, shall not be considered to be easily corrigible or reversible;
(j) the magnitude and likelihood of benefit of the deployment of the AI system for individuals, groups, or society at large,
including possible improvements in product safety;
(k) the extent to which existing Union law provides for:
(i) effective measures of redress in relation to the risks posed by an AI system, with the exclusion of claims for
damages;
(ii) effective measures to prevent or substantially minimise those risks.
3.
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to which existing Union law provides for:
(i) effective measures of redress in relation to the risks posed by an AI system, with the exclusion of claims for
damages;
(ii) effective measures to prevent or substantially minimise those risks.
3.
The Commission is empowered to adopt delegated acts in accordance with Article 97 to amend the list in Annex III
by removing high-risk AI systems where both of the following conditions are fulfilled:
(a) the high-risk AI system concerned no longer poses any significant risks to fundamental rights, health or safety, taking
into account the criteria listed in paragraph 2;
(b) the deletion does not decrease the overall level of protection of health, safety and fundamental rights under Union law.
SECTION 2
Requirements for high-risk AI systems
Article 8
Compliance with the requirements
1.
High-risk AI systems shall comply with the requirements laid down in this Section, taking into account their intended
purpose as well as the generally acknowledged state of the art on AI and AI-related technologies. The risk management
system referred to in Article 9 shall be taken into account when ensuring compliance with those requirements.
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2.
Where a product contains an AI system, to which the requirements of this Regulation as well as requirements of the
Union harmonisation legislation listed in Section A of Annex I apply, providers shall be responsible for ensuring that their
product is fully compliant with all applicable requirements under applicable Union harmonisation legislation.
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which the requirements of this Regulation as well as requirements of the
Union harmonisation legislation listed in Section A of Annex I apply, providers shall be responsible for ensuring that their
product is fully compliant with all applicable requirements under applicable Union harmonisation legislation. In ensuring
the compliance of high-risk AI systems referred to in paragraph 1 with the requirements set out in this Section, and in order
to ensure consistency, avoid duplication and minimise additional burdens, providers shall have a choice of integrating, as
appropriate, the necessary testing and reporting processes, information and documentation they provide with regard to
their product into documentation and procedures that already exist and are required under the Union harmonisation
legislation listed in Section A of Annex I.
Article 9
Risk management system
1.
A risk management system shall be established, implemented, documented and maintained in relation to high-risk AI
systems.
2.
The risk management system shall be understood as a continuous iterative process planned and run throughout the
entire lifecycle of a high-risk AI system, requiring regular systematic review and updating. It shall comprise the following
steps:
(a) the identification and analysis of the known and the reasonably foreseeable risks that the high-risk AI system can pose
to health, safety or fundamental rights when the high-risk AI system is used in accordance with its intended purpose;
(b) the estimation and evaluation of the risks that may emerge when the high-risk AI system is used in accordance with its
intended purpose, and under conditions of reasonably foreseeable misuse;
(c) the evaluation of other risks possibly arising, based on the analysis of data gathered from the post-market monitoring
system referred to in Article 72;
(d) the adoption of appropriate and targeted risk management measures designed to address the risks identified pursuant to
point (a).
3.
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This text discusses the management of risks associated with
high-risk AI systems based on
data from post-market monitoring. It emphasizes the need for targeted risk management measures to address identified risks. The risks mentioned can only be reduced or eliminated through the design and development of the
AI system or by providing sufficient technical information. The risk management measures should consider how different requirements interact to minimize risks effectively while maintaining a balance in their implementation. These measures must ensure that the remaining risks from each hazard and the overall risk of the
AI system are acceptable. To identify the best risk management strategies, the following should be ensured: (a) risks should be eliminated or reduced as much as possible through proper design and development; (b) if risks cannot be eliminated, appropriate mitigation and control measures should be implemented; (c) necessary information and training should be provided to
users. Additionally, considerations should be made regarding the technical knowledge, experience, and training expected from the
users, as well as the context in which the
AI system will be used.
possibly arising, based on the analysis of data gathered from the post-market monitoring
system referred to in Article 72;
(d) the adoption of appropriate and targeted risk management measures designed to address the risks identified pursuant to
point (a).
3.
The risks referred to in this Article shall concern only those which may be reasonably mitigated or eliminated through
the development or design of the high-risk AI system, or the provision of adequate technical information.
4.
The risk management measures referred to in paragraph 2, point (d), shall give due consideration to the effects and
possible interaction resulting from the combined application of the requirements set out in this Section, with a view to
minimising risks more effectively while achieving an appropriate balance in implementing the measures to fulfil those
requirements.
5.
The risk management measures referred to in paragraph 2, point (d), shall be such that the relevant residual risk
associated with each hazard, as well as the overall residual risk of the high-risk AI systems is judged to be acceptable.
In identifying the most appropriate risk management measures, the following shall be ensured:
(a) elimination or reduction of risks identified and evaluated pursuant to paragraph 2 in as far as technically feasible
through adequate design and development of the high-risk AI system;
(b) where appropriate, implementation of adequate mitigation and control measures addressing risks that cannot be
eliminated;
(c) provision of information required pursuant to Article 13 and, where appropriate, training to deployers.
With a view to eliminating or reducing risks related to the use of the high-risk AI system, due consideration shall be given
to the technical knowledge, experience, education, the training to be expected by the deployer, and the presumable context
in which the system is intended to be used.
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6.
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High-risk AI systems must be tested to find the best ways to manage risks. This testing ensures that these systems work reliably for their intended use and meet the requirements outlined in this section. Testing may include real-world conditions as specified in
Article 60. Testing should occur at any stage of development, but must be completed before the systems are sold or used. It will be based on predefined metrics and thresholds suitable for the system's purpose.
Providers must consider whether the
high-risk AI system could negatively affect individuals under 18 and other
vulnerable groups. For
providers already
subject to internal risk management requirements under other EU laws, the aspects mentioned may be integrated into their existing risk management processes. Additionally,
high-risk AI systems that use
data for training must be developed using training, validation, and
testing data sets that meet specific quality standards.
which the system is intended to be used.
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6.
High-risk AI systems shall be tested for the purpose of identifying the most appropriate and targeted risk management
measures. Testing shall ensure that high-risk AI systems perform consistently for their intended purpose and that they are in
compliance with the requirements set out in this Section.
7.
Testing procedures may include testing in real-world conditions in accordance with Article 60.
8.
The testing of high-risk AI systems shall be performed, as appropriate, at any time throughout the development
process, and, in any event, prior to their being placed on the market or put into service. Testing shall be carried out against
prior defined metrics and probabilistic thresholds that are appropriate to the intended purpose of the high-risk AI system.
9.
When implementing the risk management system as provided for in paragraphs 1 to 7, providers shall give
consideration to whether in view of its intended purpose the high-risk AI system is likely to have an adverse impact on
persons under the age of 18 and, as appropriate, other vulnerable groups.
10.
For providers of high-risk AI systems that are subject to requirements regarding internal risk management processes
under other relevant provisions of Union law, the aspects provided in paragraphs 1 to 9 may be part of, or combined with,
the risk management procedures established pursuant to that law.
Article 10
Data and data governance
1.
High-risk AI systems which make use of techniques involving the training of AI models with data shall be developed
on the basis of training, validation and testing data sets that meet the quality criteria referred to in paragraphs 2 to 5
whenever such data sets are used.
2.
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AI models will be trained using
data sets that meet specific quality standards for training, validation, and testing. These
data sets must follow proper
data governance and management practices tailored to the
high-risk AI system's purpose. Key practices include: (a) making relevant design choices; (b) understanding how
data is collected and its original purpose, especially for
personal data; (c) preparing
data through processes like labeling and cleaning; (d) stating assumptions about what the
data measures; (e) assessing the availability and suitability of the
data sets needed; (f) checking for biases that could harm health, violate rights, or lead to
discrimination; (g) implementing measures to detect and reduce identified biases; and (h) identifying and addressing any
data gaps that hinder compliance with regulations. The
data sets must be relevant, representative, and as error-free and complete as possible for their intended use, possessing the right statistical properties for the target population.
of techniques involving the training of AI models with data shall be developed
on the basis of training, validation and testing data sets that meet the quality criteria referred to in paragraphs 2 to 5
whenever such data sets are used.
2.
Training, validation and testing data sets shall be subject to data governance and management practices appropriate
for the intended purpose of the high-risk AI system. Those practices shall concern in particular:
(a) the relevant design choices;
(b) data collection processes and the origin of data, and in the case of personal data, the original purpose of the data
collection;
(c) relevant data-preparation processing operations, such as annotation, labelling, cleaning, updating, enrichment and
aggregation;
(d) the formulation of assumptions, in particular with respect to the information that the data are supposed to measure and
represent;
(e) an assessment of the availability, quantity and suitability of the data sets that are needed;
(f) examination in view of possible biases that are likely to affect the health and safety of persons, have a negative impact
on fundamental rights or lead to discrimination prohibited under Union law, especially where data outputs influence
inputs for future operations;
(g) appropriate measures to detect, prevent and mitigate possible biases identified according to point (f);
(h) the identification of relevant data gaps or shortcomings that prevent compliance with this Regulation, and how those
gaps and shortcomings can be addressed.
3.
Training, validation and testing data sets shall be relevant, sufficiently representative, and to the best extent possible,
free of errors and complete in view of the intended purpose. They shall have the appropriate statistical properties, including,
where applicable, as regards the persons or groups of persons in relation to whom the high-risk AI system is intended to be
used. Those characteristics of the data sets may be met at the level of individual data sets or at the level of a combination
thereof.
4.
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High-risk AI systems are designed to be used with specific individuals or groups. The
data sets used for these systems must reflect the unique geographical, contextual, behavioral, or functional aspects relevant to their intended use.
Providers of
high-risk AI systems may need to process special categories of
personal data to detect and correct bias, but this is only allowed under strict conditions to protect individuals' rights. These conditions include:
(a) Bias detection cannot be effectively achieved using other types of
data, such as synthetic or anonymized
data;
(b) The special
personal data must have restrictions on reuse and must be protected with advanced security measures, including pseudonymization;
(c) There must be
safeguards in place to secure the
personal data, including strict access controls and documentation to prevent misuse, ensuring that only authorized individuals can access this
data with confidentiality
obligations.
persons or groups of persons in relation to whom the high-risk AI system is intended to be
used. Those characteristics of the data sets may be met at the level of individual data sets or at the level of a combination
thereof.
4.
Data sets shall take into account, to the extent required by the intended purpose, the characteristics or elements that
are particular to the specific geographical, contextual, behavioural or functional setting within which the high-risk AI
system is intended to be used.
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5.
To the extent that it is strictly necessary for the purpose of ensuring bias detection and correction in relation to the
high-risk AI systems in accordance with paragraph (2), points (f) and (g) of this Article, the providers of such systems may
exceptionally process special categories of personal data, subject to appropriate safeguards for the fundamental rights and
freedoms of natural persons. In addition to the provisions set out in Regulations (EU) 2016/679 and (EU) 2018/1725 and
Directive (EU) 2016/680, all the following conditions must be met in order for such processing to occur:
(a) the bias detection and correction cannot be effectively fulfilled by processing other data, including synthetic or
anonymised data;
(b) the special categories of personal data are subject to technical limitations on the re-use of the personal data, and
state-of-the-art security and privacy-preserving measures, including pseudonymisation;
(c) the special categories of personal data are subject to measures to ensure that the personal data processed are secured,
protected, subject to suitable safeguards, including strict controls and documentation of the access, to avoid misuse and
ensure that only authorised persons have access to those personal data with appropriate confidentiality obligations;
(d) the
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To ensure the security of
personal data, it must be protected with strict controls and documented access to prevent misuse. Only authorized individuals should have access to this
data, and they must maintain confidentiality. Special categories of
personal data should not be shared or accessed by unauthorized parties. Once any bias is corrected or the
data's retention period ends, this special
data must be deleted. Records of processing activities must explain why processing special categories of
personal data was necessary to detect and correct biases, and why other
data could not be used instead. For
high-risk AI systems that do not involve training
AI models, these rules apply only to the
testing data sets.
Technical documentation for
high-risk AI systems must be created before the system is marketed or used and kept updated. This documentation should clearly show that the
AI system meets the required standards and provide necessary information for authorities to assess compliance. It must include at least the elements listed in
Annex IV.
Small and microenterprises can submit a simplified version of this documentation, and the
Commission will create a simplified form to meet their needs.
ensure that the personal data processed are secured,
protected, subject to suitable safeguards, including strict controls and documentation of the access, to avoid misuse and
ensure that only authorised persons have access to those personal data with appropriate confidentiality obligations;
(d) the special categories of personal data are not to be transmitted, transferred or otherwise accessed by other parties;
(e) the special categories of personal data are deleted once the bias has been corrected or the personal data has reached the
end of its retention period, whichever comes first;
(f) the records of processing activities pursuant to Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU)
2016/680 include the reasons why the processing of special categories of personal data was strictly necessary to detect
and correct biases, and why that objective could not be achieved by processing other data.
6.
For the development of high-risk AI systems not using techniques involving the training of AI models, paragraphs 2
to 5 apply only to the testing data sets.
Article 11
Technical documentation
1.
The technical documentation of a high-risk AI system shall be drawn up before that system is placed on the market or
put into service and shall be kept up-to date.
The technical documentation shall be drawn up in such a way as to demonstrate that the high-risk AI system complies with
the requirements set out in this Section and to provide national competent authorities and notified bodies with the
necessary information in a clear and comprehensive form to assess the compliance of the AI system with those
requirements. It shall contain, at a minimum, the elements set out in Annex IV. SMEs, including start-ups, may provide the
elements of the technical documentation specified in Annex IV in a simplified manner. To that end, the Commission shall
establish a simplified technical documentation form targeted at the needs of small and microenterprises.
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SMEs, including start-ups, may provide the
elements of the technical documentation specified in Annex IV in a simplified manner. To that end, the Commission shall
establish a simplified technical documentation form targeted at the needs of small and microenterprises. Where an SME,
including a start-up, opts to provide the information required in Annex IV in a simplified manner, it shall use the form
referred to in this paragraph. Notified bodies shall accept the form for the purposes of the conformity assessment.
2.
Where a high-risk AI system related to a product covered by the Union harmonisation legislation listed in Section
A of Annex I is placed on the market or put into service, a single set of technical documentation shall be drawn up
containing all the information set out in paragraph 1, as well as the information required under those legal acts.
3.
The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annex IV,
where necessary, to ensure that, in light of technical progress, the technical documentation provides all the information
necessary to assess the compliance of the system with the requirements set out in this Section.
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Article 12
Record-keeping
1.
High-risk AI systems shall technically allow for the automatic recording of events (logs) over the lifetime of the
system.
2.
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Article 12: Record-keeping
1.
High-risk AI systems must have the ability to automatically record events (
logs) throughout their entire lifespan.
2. To ensure traceability of how a
high-risk AI system operates, the logging features must allow for recording events that are important for:
(a) identifying situations where the
AI system may pose a risk as defined in
Article 79(1) or undergo significant changes;
(b) supporting post-market monitoring as mentioned in
Article 72; and
(c) overseeing the operation of
high-risk AI systems as described in
Article 26(5).
3. For
high-risk AI systems listed in point 1 (a) of
Annex III, the logging features must at least include:
(a) the start and end date and time for each use of the system;
(b) the reference database used to check the input
data;
(c) the input
data that matched the search;
(d) the identification of the individuals involved in verifying the results, as stated in
Article 14(5).
Article 13:
Transparency and Information for Deployers
1.
High-risk AI systems must be designed to ensure that their operation is clear enough for deployers to understand and use the system's output correctly. The level of
transparency must meet the
obligations of both the
provider and
deployer outlined in
Section 3.
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Article 12
Record-keeping
1.
High-risk AI systems shall technically allow for the automatic recording of events (logs) over the lifetime of the
system.
2.
In order to ensure a level of traceability of the functioning of a high-risk AI system that is appropriate to the intended
purpose of the system, logging capabilities shall enable the recording of events relevant for:
(a) identifying situations that may result in the high-risk AI system presenting a risk within the meaning of Article 79(1) or
in a substantial modification;
(b) facilitating the post-market monitoring referred to in Article 72; and
(c) monitoring the operation of high-risk AI systems referred to in Article 26(5).
3.
For high-risk AI systems referred to in point 1 (a), of Annex III, the logging capabilities shall provide, at a minimum:
(a) recording of the period of each use of the system (start date and time and end date and time of each use);
(b) the reference database against which input data has been checked by the system;
(c) the input data for which the search has led to a match;
(d) the identification of the natural persons involved in the verification of the results, as referred to in Article 14(5).
Article 13
Transparency and provision of information to deployers
1.
High-risk AI systems shall be designed and developed in such a way as to ensure that their operation is sufficiently
transparent to enable deployers to interpret a system’s output and use it appropriately. An appropriate type and degree of
transparency shall be ensured with a view to achieving compliance with the relevant obligations of the provider and
deployer set out in Section 3.
2.
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Users need to understand how to interpret and use the output of a system correctly. To ensure compliance with the relevant
obligations outlined in
Section 3, there must be a suitable level of
transparency.
1.
High-risk AI systems must come with user instructions in a digital format or another accessible form. These instructions should provide clear, complete, and accurate information that is easy for
users to understand.
2. The user instructions must include at least the following details:
(a) The identity and contact information of the
provider and, if applicable, their authorized representative.
(b) The features, capabilities, and performance limitations of the
high-risk AI system, including:
(i) Its intended purpose.
(ii) The expected
accuracy level, including metrics,
robustness, and
cybersecurity measures as mentioned in
Article 15, along with any known factors that could affect this
accuracy.
(iii) Any known or foreseeable situations related to the use of the
high-risk AI system that could pose risks to health, safety, or
fundamental rights as stated in
Article 9(2).
(iv) If relevant, the technical features of the
high-risk AI system that help explain its output.
ers to interpret a system’s output and use it appropriately. An appropriate type and degree of
transparency shall be ensured with a view to achieving compliance with the relevant obligations of the provider and
deployer set out in Section 3.
2.
High-risk AI systems shall be accompanied by instructions for use in an appropriate digital format or otherwise that
include concise, complete, correct and clear information that is relevant, accessible and comprehensible to deployers.
3.
The instructions for use shall contain at least the following information:
(a) the identity and the contact details of the provider and, where applicable, of its authorised representative;
(b) the characteristics, capabilities and limitations of performance of the high-risk AI system, including:
(i) its intended purpose;
(ii) the level of accuracy, including its metrics, robustness and cybersecurity referred to in Article 15 against which the
high-risk AI system has been tested and validated and which can be expected, and any known and foreseeable
circumstances that may have an impact on that expected level of accuracy, robustness and cybersecurity;
(iii) any known or foreseeable circumstance, related to the use of the high-risk AI system in accordance with its
intended purpose or under conditions of reasonably foreseeable misuse, which may lead to risks to the health and
safety or fundamental rights referred to in Article 9(2);
(iv) where applicable, the technical capabilities and characteristics of the high-risk AI system to provide information
that is relevant to explain its output;
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The following points outline important information regarding
high-risk AI systems:
1. Safety and
fundamental rights mentioned in
Article 9(2) must be considered.
2. If applicable, the technical features of the
AI system should provide relevant information to explain its outputs.
3. The system's performance should be evaluated for specific individuals or groups it is intended to serve.
4. Specifications for input
data and other relevant details about the training, validation, and testing datasets should be provided, considering the system's intended purpose.
5. Information should be available to help
users interpret the
AI system's outputs correctly.
6. Any changes to the
AI system and its performance that were identified by the
provider during the initial assessment should be documented.
7.
Human oversight measures, as mentioned in
Article 14, should include technical tools to help
users understand the
AI outputs.
8. Details about the computational and
hardware resources required, the expected lifespan of the
AI system, and necessary maintenance measures (including frequency) should be included to ensure proper functioning, including software updates.
9. If relevant, a description of the mechanisms for collecting, storing, and interpreting
logs in accordance with
Article 12 should be provided.
Article 14 emphasizes that
high-risk AI systems must be designed to allow effective
human oversight during their use, including appropriate human-machine interface tools.
afety or fundamental rights referred to in Article 9(2);
(iv) where applicable, the technical capabilities and characteristics of the high-risk AI system to provide information
that is relevant to explain its output;
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(v) when appropriate, its performance regarding specific persons or groups of persons on which the system is
intended to be used;
(vi) when appropriate, specifications for the input data, or any other relevant information in terms of the training,
validation and testing data sets used, taking into account the intended purpose of the high-risk AI system;
(vii) where applicable, information to enable deployers to interpret the output of the high-risk AI system and use it
appropriately;
(c) the changes to the high-risk AI system and its performance which have been pre-determined by the provider at the
moment of the initial conformity assessment, if any;
(d) the human oversight measures referred to in Article 14, including the technical measures put in place to facilitate the
interpretation of the outputs of the high-risk AI systems by the deployers;
(e) the computational and hardware resources needed, the expected lifetime of the high-risk AI system and any necessary
maintenance and care measures, including their frequency, to ensure the proper functioning of that AI system, including
as regards software updates;
(f) where relevant, a description of the mechanisms included within the high-risk AI system that allows deployers to
properly collect, store and interpret the logs in accordance with Article 12.
Article 14
Human oversight
1.
High-risk AI systems shall be designed and developed in such a way, including with appropriate human-machine
interface tools, that they can be effectively overseen by natural persons during the period in which they are in use.
2.
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Human Oversight of
High-Risk AI Systems
1.
High-risk AI systems must be designed to allow effective
human oversight while they are in use, using suitable human-machine interface tools.
2. The goal of
human oversight is to reduce risks to health, safety, or
fundamental rights that may arise when using
high-risk AI systems, whether used as intended or misused, especially when other safety measures are not enough.
3. Oversight measures should match the risks, autonomy level, and usage context of the
high-risk AI system. These measures can be implemented in one or both of the following ways:
(a) Built into the
AI system by the
provider before it is sold or used, if technically possible;
(b) Identified by the
provider before market release and suitable for the user to implement.
4. To ensure effective oversight, the
high-risk AI system must be provided to
users in a way that allows them to:
(a) Understand its capabilities and limitations, and monitor its operation to identify and address any issues;
(b) Be aware of the risk of over-relying on the
AI's output (
automation bias), especially when the
AI provides information or recommendations for human decisions;
(c) Accurately interpret the
AI's output, considering available interpretation tools and methods.
Human oversight
1.
High-risk AI systems shall be designed and developed in such a way, including with appropriate human-machine
interface tools, that they can be effectively overseen by natural persons during the period in which they are in use.
2.
Human oversight shall aim to prevent or minimise the risks to health, safety or fundamental rights that may emerge
when a high-risk AI system is used in accordance with its intended purpose or under conditions of reasonably foreseeable
misuse, in particular where such risks persist despite the application of other requirements set out in this Section.
3.
The oversight measures shall be commensurate with the risks, level of autonomy and context of use of the high-risk
AI system, and shall be ensured through either one or both of the following types of measures:
(a) measures identified and built, when technically feasible, into the high-risk AI system by the provider before it is placed
on the market or put into service;
(b) measures identified by the provider before placing the high-risk AI system on the market or putting it into service and
that are appropriate to be implemented by the deployer.
4.
For the purpose of implementing paragraphs 1, 2 and 3, the high-risk AI system shall be provided to the deployer in
such a way that natural persons to whom human oversight is assigned are enabled, as appropriate and proportionate:
(a) to properly understand the relevant capacities and limitations of the high-risk AI system and be able to duly monitor its
operation, including in view of detecting and addressing anomalies, dysfunctions and unexpected performance;
(b) to remain aware of the possible tendency of automatically relying or over-relying on the output produced by a high-risk
AI system (automation bias), in particular for high-risk AI systems used to provide information or recommendations for
decisions to be taken by natural persons;
(c) to correctly interpret the high-risk AI system’s output, taking into account, for example, the interpretation tools and
methods
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High-risk AI systems that provide information or recommendations for decisions made by people must:
1. Correctly interpret the system's output, using available interpretation tools and methods.
2. Allow
users to choose not to use the system's output in specific situations, or to override or reverse the system's recommendations.
3. Enable
users to intervene in the system's operation or stop it safely using a 'stop' button or similar method.
For
high-risk AI systems mentioned in
Annex III, no actions or decisions should be made based on the system's identification results unless these results have been verified and confirmed by at least two qualified individuals. However, this verification requirement does not apply to
high-risk AI systems used in
law enforcement,
migration, border control, or
asylum cases, where it may be deemed excessive by
Union or national law.
Additionally,
high-risk AI systems must be designed to ensure
accuracy,
robustness, and
cybersecurity, maintaining consistent performance throughout their lifecycle.
in particular for high-risk AI systems used to provide information or recommendations for
decisions to be taken by natural persons;
(c) to correctly interpret the high-risk AI system’s output, taking into account, for example, the interpretation tools and
methods available;
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(d) to decide, in any particular situation, not to use the high-risk AI system or to otherwise disregard, override or reverse
the output of the high-risk AI system;
(e) to intervene in the operation of the high-risk AI system or interrupt the system through a ‘stop’ button or a similar
procedure that allows the system to come to a halt in a safe state.
5.
For high-risk AI systems referred to in point 1(a) of Annex III, the measures referred to in paragraph 3 of this Article
shall be such as to ensure that, in addition, no action or decision is taken by the deployer on the basis of the identification
resulting from the system unless that identification has been separately verified and confirmed by at least two natural
persons with the necessary competence, training and authority.
The requirement for a separate verification by at least two natural persons shall not apply to high-risk AI systems used for
the purposes of law enforcement, migration, border control or asylum, where Union or national law considers the
application of this requirement to be disproportionate.
Article 15
Accuracy, robustness and cybersecurity
1.
High-risk AI systems shall be designed and developed in such a way that they achieve an appropriate level of accuracy,
robustness, and cybersecurity, and that they perform consistently in those respects throughout their lifecycle.
2.
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1.
High-risk AI systems must be designed to achieve a suitable level of
accuracy,
robustness, and
cybersecurity, and they should maintain these qualities throughout their entire lifecycle. 2. To help measure the necessary levels of
accuracy and
robustness mentioned in point 1, the
Commission will work with relevant
stakeholders and organizations, like
metrology and benchmarking authorities, to promote the development of
benchmarks and measurement methods. 3. The
accuracy levels and metrics for
high-risk AI systems must be included in the user instructions. 4.
High-risk AI systems should be as resilient as possible to errors, faults, or inconsistencies that may arise from their interactions with people or other systems. This requires both technical and organizational measures.
Robustness can be enhanced through
technical redundancy solutions, such as backup plans. For
high-risk AI systems that continue to learn after being released, developers must minimize the risk of biased outputs affecting future operations (
feedback loops) and ensure that any such
feedback loops are properly managed with mitigation measures. 5.
High-risk AI systems must be protected against unauthorized attempts to change their use, outputs, or performance by exploiting vulnerabilities. The
technical solutions for ensuring the
cybersecurity of these systems should be suitable for the specific circumstances and risks involved.
ness and cybersecurity
1.
High-risk AI systems shall be designed and developed in such a way that they achieve an appropriate level of accuracy,
robustness, and cybersecurity, and that they perform consistently in those respects throughout their lifecycle.
2.
To address the technical aspects of how to measure the appropriate levels of accuracy and robustness set out in
paragraph 1 and any other relevant performance metrics, the Commission shall, in cooperation with relevant stakeholders
and organisations such as metrology and benchmarking authorities, encourage, as appropriate, the development of
benchmarks and measurement methodologies.
3.
The levels of accuracy and the relevant accuracy metrics of high-risk AI systems shall be declared in the accompanying
instructions of use.
4.
High-risk AI systems shall be as resilient as possible regarding errors, faults or inconsistencies that may occur within
the system or the environment in which the system operates, in particular due to their interaction with natural persons or
other systems. Technical and organisational measures shall be taken in this regard.
The robustness of high-risk AI systems may be achieved through technical redundancy solutions, which may include
backup or fail-safe plans.
High-risk AI systems that continue to learn after being placed on the market or put into service shall be developed in such
a way as to eliminate or reduce as far as possible the risk of possibly biased outputs influencing input for future operations
(feedback loops), and as to ensure that any such feedback loops are duly addressed with appropriate mitigation measures.
5.
High-risk AI systems shall be resilient against attempts by unauthorised third parties to alter their use, outputs or
performance by exploiting system vulnerabilities.
The technical solutions aiming to ensure the cybersecurity of high-risk AI systems shall be appropriate to the relevant
circumstances and the risks.
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High-risk AI systems must be protected from unauthorized attempts to change their use, outputs, or performance by taking advantage of system weaknesses. The
technical solutions for ensuring the
cybersecurity of these systems should be suitable for the specific risks involved. These solutions should address vulnerabilities unique to
AI, including measures to prevent, detect, respond to, resolve, and control attacks that could manipulate
training data (
data poisoning), pre-trained components (model poisoning), inputs that lead to mistakes (adversarial examples), confidentiality breaches, or flaws in the model.
**
Obligations of
Providers of
High-Risk AI Systems**
Providers of
high-risk AI systems must:
(a) Ensure their systems meet the requirements outlined in
Section 2;
(b) Clearly display their name, trade name, or trademark, along with their contact address on the system, its packaging, or accompanying documents;
(c) Implement a
quality management system as per
Article 17;
(d) Maintain the documentation specified in
Article 18;
(e) Keep
logs generated by their
AI systems as mentioned in
Article 19;
(f) Ensure the system passes the necessary
conformity assessment before being sold or used, as stated in
Article 43;
(g) Create an
EU declaration of conformity according to
Article 47;
(h) Affix the CE mark.
resilient against attempts by unauthorised third parties to alter their use, outputs or
performance by exploiting system vulnerabilities.
The technical solutions aiming to ensure the cybersecurity of high-risk AI systems shall be appropriate to the relevant
circumstances and the risks.
The technical solutions to address AI specific vulnerabilities shall include, where appropriate, measures to prevent, detect,
respond to, resolve and control for attacks trying to manipulate the training data set (data poisoning), or pre-trained
components used in training (model poisoning), inputs designed to cause the AI model to make a mistake (adversarial
examples or model evasion), confidentiality attacks or model flaws.
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SECTION 3
Obligations of providers and deployers of high-risk AI systems and other parties
Article 16
Obligations of providers of high-risk AI systems
Providers of high-risk AI systems shall:
(a) ensure that their high-risk AI systems are compliant with the requirements set out in Section 2;
(b) indicate on the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation,
as applicable, their name, registered trade name or registered trade mark, the address at which they can be contacted;
(c) have a quality management system in place which complies with Article 17;
(d) keep the documentation referred to in Article 18;
(e) when under their control, keep the logs automatically generated by their high-risk AI systems as referred to in
Article 19;
(f) ensure that the high-risk AI system undergoes the relevant conformity assessment procedure as referred to in Article 43,
prior to its being placed on the market or put into service;
(g) draw up an EU declaration of conformity in accordance with Article 47;
(h) affix the CE
Show original text
Before a
high-risk AI system can be sold or used,
providers must follow specific steps: (f) complete the necessary
conformity assessment procedure as outlined in
Article 43; (g) create an
EU declaration of conformity as per
Article 47; (h) place the
CE marking on the
AI system, or on its packaging or accompanying documents, to show it meets this
Regulation, according to
Article 48; (i) fulfill the registration requirements mentioned in
Article 49(1); (j) take corrective actions and provide information as needed in
Article 20; (k) if requested by a national authority, prove that the
AI system meets the requirements in
Section 2; (l) ensure the
AI system meets accessibility standards as per Directives (EU) 2016/2102 and (EU) 2019/882.
Article 17 states that
providers of
high-risk AI systems must establish a
quality management system to ensure compliance with this
Regulation. This system must be documented clearly and include: (a) a strategy for regulatory compliance, including
conformity assessment procedures and management of system modifications; (b) methods for design control and verification; (c) processes for development, quality control, and assurance; (d) testing and validation procedures to be conducted before, during, and after development, along with their frequency.
es the relevant conformity assessment procedure as referred to in Article 43,
prior to its being placed on the market or put into service;
(g) draw up an EU declaration of conformity in accordance with Article 47;
(h) affix the CE marking to the high-risk AI system or, where that is not possible, on its packaging or its accompanying
documentation, to indicate conformity with this Regulation, in accordance with Article 48;
(i) comply with the registration obligations referred to in Article 49(1);
(j) take the necessary corrective actions and provide information as required in Article 20;
(k) upon a reasoned request of a national competent authority, demonstrate the conformity of the high-risk AI system with
the requirements set out in Section 2;
(l) ensure that the high-risk AI system complies with accessibility requirements in accordance with Directives (EU)
2016/2102 and (EU) 2019/882.
Article 17
Quality management system
1.
Providers of high-risk AI systems shall put a quality management system in place that ensures compliance with this
Regulation. That system shall be documented in a systematic and orderly manner in the form of written policies, procedures
and instructions, and shall include at least the following aspects:
(a)
a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for
the management of modifications to the high-risk AI system;
(b) techniques, procedures and systematic actions to be used for the design, design control and design verification of the
high-risk AI system;
(c)
techniques, procedures and systematic actions to be used for the development, quality control and quality assurance of
the high-risk AI system;
(d) examination, test and validation procedures to be carried out before, during and after the development of the high-risk
AI system, and the frequency with which they have to be carried out;
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(d) Procedures for examining, testing, and validating
high-risk AI systems must be conducted before, during, and after development, along with the frequency of these procedures; (e) Technical specifications and standards that must be followed. If the relevant standards are not fully applied or do not cover all necessary requirements, alternative methods must be used to ensure compliance; (f) Systems and procedures for managing
data, including how
data is acquired, collected, analyzed, labeled, stored, filtered, mined, aggregated, retained, and any other operations related to
data before the
high-risk AI systems are marketed or put into service; (g) The
risk management system as mentioned in
Article 9; (h) Establishing, implementing, and maintaining a
post-market monitoring system as per
Article 72; (i) Procedures for reporting serious incidents according to
Article 73; (j) Managing communication with
national authorities, relevant agencies,
notified bodies, other operators, customers, and interested parties; (k) Systems and procedures for keeping records of all relevant documents and information; (l) Resource management, including measures related to supply security; (m) An
accountability framework that defines the responsibilities of management and staff regarding all aspects mentioned. The implementation of these aspects should be appropriate to the size of the
provider's organization.
(d) examination, test and validation procedures to be carried out before, during and after the development of the high-risk
AI system, and the frequency with which they have to be carried out;
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(e)
technical specifications, including standards, to be applied and, where the relevant harmonised standards are not
applied in full or do not cover all of the relevant requirements set out in Section 2, the means to be used to ensure that
the high-risk AI system complies with those requirements;
(f)
systems and procedures for data management, including data acquisition, data collection, data analysis, data labelling,
data storage, data filtration, data mining, data aggregation, data retention and any other operation regarding the data
that is performed before and for the purpose of the placing on the market or the putting into service of high-risk AI
systems;
(g) the risk management system referred to in Article 9;
(h) the setting-up, implementation and maintenance of a post-market monitoring system, in accordance with Article 72;
(i)
procedures related to the reporting of a serious incident in accordance with Article 73;
(j)
the handling of communication with national competent authorities, other relevant authorities, including those
providing or supporting the access to data, notified bodies, other operators, customers or other interested parties;
(k) systems and procedures for record-keeping of all relevant documentation and information;
(l)
resource management, including security-of-supply related measures;
(m) an accountability framework setting out the responsibilities of the management and other staff with regard to all the
aspects listed in this paragraph.
2.
The implementation of the aspects referred to in paragraph 1 shall be proportionate to the size of the provider’s
organisation.
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setting out the responsibilities of the management and other staff with regard to all the
aspects listed in this paragraph.
2.
The implementation of the aspects referred to in paragraph 1 shall be proportionate to the size of the provider’s
organisation. Providers shall, in any event, respect the degree of rigour and the level of protection required to ensure the
compliance of their high-risk AI systems with this Regulation.
3.
Providers of high-risk AI systems that are subject to obligations regarding quality management systems or an
equivalent function under relevant sectoral Union law may include the aspects listed in paragraph 1 as part of the quality
management systems pursuant to that law.
4.
For providers that are financial institutions subject to requirements regarding their internal governance, arrangements
or processes under Union financial services law, the obligation to put in place a quality management system, with the
exception of paragraph 1, points (g), (h) and (i) of this Article, shall be deemed to be fulfilled by complying with the rules on
internal governance arrangements or processes pursuant to the relevant Union financial services law. To that end, any
harmonised standards referred to in Article 40 shall be taken into account.
Article 18
Documentation keeping
1.
The provider shall, for a period ending 10 years after the high-risk AI system has been placed on the market or put
into service, keep at the disposal of the national competent authorities:
(a) the technical documentation referred to in Article 11;
(b) the documentation concerning the quality management system referred to in Article 17;
(c) the documentation concerning the changes approved by notified bodies, where applicable;
(d) the decisions and other documents issued by the notified bodies, where applicable;
(e) the EU declaration of conformity referred to in Article 47.
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Regarding the changes approved by
notified bodies, and any decisions or documents they issue, the
EU declaration of conformity mentioned in
Article 47 must also be included. Each
Member State will set the rules for how long this documentation must be available to
national authorities, especially if a
provider or their authorized representative goes bankrupt or stops operating before the specified time. Financial institutions that must follow specific internal governance rules under EU financial services law must keep their
technical documentation as required by that law.
Article 19 states that
providers of
high-risk AI systems must keep automatically generated
logs for at least six months, or longer if required by EU or
national law, including laws on
personal data protection. Financial institutions must also maintain these
logs as part of their required documentation under financial services law.
Article 20 discusses corrective actions and the obligation to provide information.
concerning the changes approved by notified bodies, where applicable;
(d) the decisions and other documents issued by the notified bodies, where applicable;
(e) the EU declaration of conformity referred to in Article 47.
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2.
Each Member State shall determine conditions under which the documentation referred to in paragraph 1 remains at
the disposal of the national competent authorities for the period indicated in that paragraph for the cases when a provider
or its authorised representative established on its territory goes bankrupt or ceases its activity prior to the end of that
period.
3.
Providers that are financial institutions subject to requirements regarding their internal governance, arrangements or
processes under Union financial services law shall maintain the technical documentation as part of the documentation kept
under the relevant Union financial services law.
Article 19
Automatically generated logs
1.
Providers of high-risk AI systems shall keep the logs referred to in Article 12(1), automatically generated by their
high-risk AI systems, to the extent such logs are under their control. Without prejudice to applicable Union or national law,
the logs shall be kept for a period appropriate to the intended purpose of the high-risk AI system, of at least six months,
unless provided otherwise in the applicable Union or national law, in particular in Union law on the protection of personal
data.
2.
Providers that are financial institutions subject to requirements regarding their internal governance, arrangements or
processes under Union financial services law shall maintain the logs automatically generated by their high-risk AI systems
as part of the documentation kept under the relevant financial services law.
Article 20
Corrective actions and duty of information
1.
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Companies that provide
high-risk AI systems must keep records of the
logs automatically created by these systems, as required by
Union financial services law.
**
Article 20: Corrective Actions and Duty to Inform**
1. If a
provider believes that their
high-risk AI system does not comply with regulations, they must quickly take corrective actions. This may include fixing the system, withdrawing it from the market, disabling it, or recalling it. They must also inform distributors, deployers, authorized representatives, and importers about the situation.
2. If the
high-risk AI system poses a risk, the
provider must investigate the issue immediately, working with the
deployer if necessary. They must inform the relevant
market surveillance authorities and, if applicable, the
notified body that certified the system about the non-compliance and any corrective actions taken.
**
Article 21: Cooperation with
Competent Authorities**
1.
Providers of
high-risk AI systems must provide any requested information and documentation to
competent authorities to prove that their system meets the required standards. This information should be in a language that the authority can easily understand, using one of the official languages of the
Union as specified by the relevant
Member State.
arrangements or
processes under Union financial services law shall maintain the logs automatically generated by their high-risk AI systems
as part of the documentation kept under the relevant financial services law.
Article 20
Corrective actions and duty of information
1.
Providers of high-risk AI systems which consider or have reason to consider that a high-risk AI system that they have
placed on the market or put into service is not in conformity with this Regulation shall immediately take the necessary
corrective actions to bring that system into conformity, to withdraw it, to disable it, or to recall it, as appropriate. They shall
inform the distributors of the high-risk AI system concerned and, where applicable, the deployers, the authorised
representative and importers accordingly.
2.
Where the high-risk AI system presents a risk within the meaning of Article 79(1) and the provider becomes aware of
that risk, it shall immediately investigate the causes, in collaboration with the reporting deployer, where applicable, and
inform the market surveillance authorities competent for the high-risk AI system concerned and, where applicable, the
notified body that issued a certificate for that high-risk AI system in accordance with Article 44, in particular, of the nature
of the non-compliance and of any relevant corrective action taken.
Article 21
Cooperation with competent authorities
1.
Providers of high-risk AI systems shall, upon a reasoned request by a competent authority, provide that authority all
the information and documentation necessary to demonstrate the conformity of the high-risk AI system with the
requirements set out in Section 2, in a language which can be easily understood by the authority in one of the official
languages of the institutions of the Union as indicated by the Member State concerned.
2.
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the high-risk AI system with the
requirements set out in Section 2, in a language which can be easily understood by the authority in one of the official
languages of the institutions of the Union as indicated by the Member State concerned.
2.
Upon a reasoned request by a competent authority, providers shall also give the requesting competent authority, as
applicable, access to the automatically generated logs of the high-risk AI system referred to in Article 12(1), to the extent
such logs are under their control.
3.
Any information obtained by a competent authority pursuant to this Article shall be treated in accordance with the
confidentiality obligations set out in Article 78.
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Article 22
Authorised representatives of providers of high-risk AI systems
1.
Prior to making their high-risk AI systems available on the Union market, providers established in third countries
shall, by written mandate, appoint an authorised representative which is established in the Union.
2.
The provider shall enable its authorised representative to perform the tasks specified in the mandate received from the
provider.
3.
The authorised representative shall perform the tasks specified in the mandate received from the provider. It shall
provide a copy of the mandate to the market surveillance authorities upon request, in one of the official languages of the
institutions of the Union, as indicated by the competent authority.
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The authorized representative must carry out tasks outlined in the
mandate from the
provider. They must provide a copy of this
mandate to
market surveillance authorities if requested, in one of the official languages of the EU, as specified by the
competent authority. The
mandate allows the authorized representative to perform the following tasks: (a) Check that the
EU declaration of conformity (mentioned in
Article 47) and the
technical documentation (mentioned in
Article 11) have been completed, and that the
provider has conducted the necessary
conformity assessment; (b) Keep the contact details of the
provider, a copy of the
EU declaration of conformity, the
technical documentation, and any relevant
certificates available for competent and
national authorities for
10 years after the
high-risk AI system is on the market or in use; (c) Provide any requested information and documentation to a
competent authority to prove that the
high-risk AI system meets the requirements in
Section 2, including access to
logs generated by the system, as long as those
logs are controlled by the
provider; (d) Work with
competent authorities on any actions they take regarding the
high-risk AI system, especially to reduce and manage risks; (e) If applicable, fulfill the registration requirements mentioned in
Article 49(1), or ensure that the
provider registers the necessary information as outlined in point 3 of Section A of the Annex.
the tasks specified in the mandate received from the provider. It shall
provide a copy of the mandate to the market surveillance authorities upon request, in one of the official languages of the
institutions of the Union, as indicated by the competent authority. For the purposes of this Regulation, the mandate shall
empower the authorised representative to carry out the following tasks:
(a) verify that the EU declaration of conformity referred to in Article 47 and the technical documentation referred to in
Article 11 have been drawn up and that an appropriate conformity assessment procedure has been carried out by the
provider;
(b) keep at the disposal of the competent authorities and national authorities or bodies referred to in Article 74(10), for
a period of 10 years after the high-risk AI system has been placed on the market or put into service, the contact details
of the provider that appointed the authorised representative, a copy of the EU declaration of conformity referred to in
Article 47, the technical documentation and, if applicable, the certificate issued by the notified body;
(c) provide a competent authority, upon a reasoned request, with all the information and documentation, including that
referred to in point (b) of this subparagraph, necessary to demonstrate the conformity of a high-risk AI system with the
requirements set out in Section 2, including access to the logs, as referred to in Article 12(1), automatically generated by
the high-risk AI system, to the extent such logs are under the control of the provider;
(d) cooperate with competent authorities, upon a reasoned request, in any action the latter take in relation to the high-risk
AI system, in particular to reduce and mitigate the risks posed by the high-risk AI system;
(e) where applicable, comply with the registration obligations referred to in Article 49(1), or, if the registration is carried
out by the provider itself, ensure that the information referred to in point 3 of Section A of Annex
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system;
(e) where applicable, comply with the registration obligations referred to in Article 49(1), or, if the registration is carried
out by the provider itself, ensure that the information referred to in point 3 of Section A of Annex VIII is correct.
The mandate shall empower the authorised representative to be addressed, in addition to or instead of the provider, by the
competent authorities, on all issues related to ensuring compliance with this Regulation.
4.
The authorised representative shall terminate the mandate if it considers or has reason to consider the provider to be
acting contrary to its obligations pursuant to this Regulation. In such a case, it shall immediately inform the relevant market
surveillance authority, as well as, where applicable, the relevant notified body, about the termination of the mandate and the
reasons therefor.
Article 23
Obligations of importers
1.
Before placing a high-risk AI system on the market, importers shall ensure that the system is in conformity with this
Regulation by verifying that:
(a) the relevant conformity assessment procedure referred to in Article 43 has been carried out by the provider of the
high-risk AI system;
(b) the provider has drawn up the technical documentation in accordance with Article 11 and Annex IV;
(c) the system bears the required CE marking and is accompanied by the EU declaration of conformity referred to in
Article 47 and instructions for use;
(d) the provider has appointed an authorised representative in accordance with Article 22(1).
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2.
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According to
Article 22(1), as published in
OJ L on July 12, 2024, importers must not sell a
high-risk AI system if they have good reason to believe it does not comply with regulations, is counterfeit, or has fake documents. They must ensure the system is compliant before placing it on the market. If the system poses a risk as defined in
Article 79(1), the
importer must notify the system
provider, the authorized representative, and
market surveillance authorities.
Importers are required to display their name, registered trade name or trademark, and contact address on the
high-risk AI system, its packaging, or accompanying documents, if applicable. They must also ensure that the storage or transport conditions of the
AI system do not compromise its compliance with regulations while it is under their responsibility.
Importers must keep a copy of the certificate from the
notified body, the user instructions, and the
EU declaration of conformity for
10 years after the
AI system is sold or put into service. They must provide relevant authorities with all necessary information and documentation, including what is mentioned above, in a language that is easy for them to understand, upon a justified request. They should also ensure that the
technical documentation is accessible to these authorities.
in accordance with Article 22(1).
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2.
Where an importer has sufficient reason to consider that a high-risk AI system is not in conformity with this
Regulation, or is falsified, or accompanied by falsified documentation, it shall not place the system on the market until it has
been brought into conformity. Where the high-risk AI system presents a risk within the meaning of Article 79(1), the
importer shall inform the provider of the system, the authorised representative and the market surveillance authorities to
that effect.
3.
Importers shall indicate their name, registered trade name or registered trade mark, and the address at which they can
be contacted on the high-risk AI system and on its packaging or its accompanying documentation, where applicable.
4.
Importers shall ensure that, while a high-risk AI system is under their responsibility, storage or transport conditions,
where applicable, do not jeopardise its compliance with the requirements set out in Section 2.
5.
Importers shall keep, for a period of 10 years after the high-risk AI system has been placed on the market or put into
service, a copy of the certificate issued by the notified body, where applicable, of the instructions for use, and of the EU
declaration of conformity referred to in Article 47.
6.
Importers shall provide the relevant competent authorities, upon a reasoned request, with all the necessary
information and documentation, including that referred to in paragraph 5, to demonstrate the conformity of a high-risk AI
system with the requirements set out in Section 2 in a language which can be easily understood by them. For this purpose,
they shall also ensure that the technical documentation can be made available to those authorities.
7.
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of a high-risk AI
system with the requirements set out in Section 2 in a language which can be easily understood by them. For this purpose,
they shall also ensure that the technical documentation can be made available to those authorities.
7.
Importers shall cooperate with the relevant competent authorities in any action those authorities take in relation to
a high-risk AI system placed on the market by the importers, in particular to reduce and mitigate the risks posed by it.
Article 24
Obligations of distributors
1.
Before making a high-risk AI system available on the market, distributors shall verify that it bears the required CE
marking, that it is accompanied by a copy of the EU declaration of conformity referred to in Article 47 and instructions for
use, and that the provider and the importer of that system, as applicable, have complied with their respective obligations as
laid down in Article 16, points (b) and (c) and Article 23(3).
2.
Where a distributor considers or has reason to consider, on the basis of the information in its possession, that
a high-risk AI system is not in conformity with the requirements set out in Section 2, it shall not make the high-risk AI
system available on the market until the system has been brought into conformity with those requirements. Furthermore,
where the high-risk AI system presents a risk within the meaning of Article 79(1), the distributor shall inform the provider
or the importer of the system, as applicable, to that effect.
3.
Distributors shall ensure that, while a high-risk AI system is under their responsibility, storage or transport
conditions, where applicable, do not jeopardise the compliance of the system with the requirements set out in Section 2.
4.
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3. Distributors must ensure that the storage and transport conditions of
high-risk AI systems do not compromise their compliance with the requirements outlined in
Section 2. 4. If a
distributor believes that a
high-risk AI system they have made available is not compliant with
Section 2, they must take necessary corrective actions to ensure compliance, withdraw the system, or recall it. They should also ensure that the
provider,
importer, or relevant
operator takes these actions. If the system poses a risk as defined in
Article 79(1), the
distributor must immediately inform the
provider or
importer and the relevant authorities, detailing the non-compliance and any corrective actions taken. 5. Distributors must provide any requested information and documentation to relevant authorities to demonstrate compliance with
Section 2. 6. Distributors are required to cooperate with relevant authorities in any actions they take regarding
high-risk AI systems they have made available, especially to reduce or mitigate risks.
3.
Distributors shall ensure that, while a high-risk AI system is under their responsibility, storage or transport
conditions, where applicable, do not jeopardise the compliance of the system with the requirements set out in Section 2.
4.
A distributor that considers or has reason to consider, on the basis of the information in its possession, a high-risk AI
system which it has made available on the market not to be in conformity with the requirements set out in Section 2, shall
take the corrective actions necessary to bring that system into conformity with those requirements, to withdraw it or recall
it, or shall ensure that the provider, the importer or any relevant operator, as appropriate, takes those corrective actions.
Where the high-risk AI system presents a risk within the meaning of Article 79(1), the distributor shall immediately inform
the provider or importer of the system and the authorities competent for the high-risk AI system concerned, giving details,
in particular, of the non-compliance and of any corrective actions taken.
5.
Upon a reasoned request from a relevant competent authority, distributors of a high-risk AI system shall provide that
authority with all the information and documentation regarding their actions pursuant to paragraphs 1 to 4 necessary to
demonstrate the conformity of that system with the requirements set out in Section 2.
6.
Distributors shall cooperate with the relevant competent authorities in any action those authorities take in relation to
a high-risk AI system made available on the market by the distributors, in particular to reduce or mitigate the risk posed by
it.
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Article 25
Responsibilities along the AI value chain
1.
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Article 25
Responsibilities along the AI value chain
1.
Any distributor, importer, deployer or other third-party shall be considered to be a provider of a high-risk AI system
for the purposes of this Regulation and shall be subject to the obligations of the provider under Article 16, in any of the
following circumstances:
(a) they put their name or trademark on a high-risk AI system already placed on the market or put into service, without
prejudice to contractual arrangements stipulating that the obligations are otherwise allocated;
(b) they make a substantial modification to a high-risk AI system that has already been placed on the market or has already
been put into service in such a way that it remains a high-risk AI system pursuant to Article 6;
(c) they modify the intended purpose of an AI system, including a general-purpose AI system, which has not been classified
as high-risk and has already been placed on the market or put into service in such a way that the AI system concerned
becomes a high-risk AI system in accordance with Article 6.
2.
Where the circumstances referred to in paragraph 1 occur, the provider that initially placed the AI system on the
market or put it into service shall no longer be considered to be a provider of that specific AI system for the purposes of
this Regulation. That initial provider shall closely cooperate with new providers and shall make available the necessary
information and provide the reasonably expected technical access and other assistance that are required for the fulfilment of
the obligations set out in this Regulation, in particular regarding the compliance with the conformity assessment of
high-risk AI systems.
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The necessary information and technical support must be provided to meet the requirements of this
Regulation, especially for ensuring that
high-risk AI systems comply with conformity assessments. However, this does not apply if the original
provider has clearly stated that their
AI system should not be classified as high-risk and therefore does not need to share documentation.
For
high-risk AI systems that are
safety components of products covered by EU regulations listed in
Section A of Annex I, the
product manufacturer will be considered the
provider of the
high-risk AI system and must follow the
obligations in
Article 16 if:
(a) the
high-risk AI system is marketed with the product under the manufacturer's name or trademark;
(b) the
high-risk AI system is used under the manufacturer's name or trademark after the product has been sold.
The
provider of a
high-risk AI system and any
third party supplying
AI systems, tools, services, components, or processes used in the
high-risk AI system must agree in writing on the necessary information, capabilities, technical access, and support needed to ensure compliance with this
Regulation. This requirement does not apply to third parties offering tools, services, processes, or components to the public under a free and
open-source license, except for
general-purpose AI models.
shall make available the necessary
information and provide the reasonably expected technical access and other assistance that are required for the fulfilment of
the obligations set out in this Regulation, in particular regarding the compliance with the conformity assessment of
high-risk AI systems. This paragraph shall not apply in cases where the initial provider has clearly specified that its AI
system is not to be changed into a high-risk AI system and therefore does not fall under the obligation to hand over the
documentation.
3.
In the case of high-risk AI systems that are safety components of products covered by the Union harmonisation
legislation listed in Section A of Annex I, the product manufacturer shall be considered to be the provider of the high-risk
AI system, and shall be subject to the obligations under Article 16 under either of the following circumstances:
(a) the high-risk AI system is placed on the market together with the product under the name or trademark of the product
manufacturer;
(b) the high-risk AI system is put into service under the name or trademark of the product manufacturer after the product
has been placed on the market.
4.
The provider of a high-risk AI system and the third party that supplies an AI system, tools, services, components, or
processes that are used or integrated in a high-risk AI system shall, by written agreement, specify the necessary information,
capabilities, technical access and other assistance based on the generally acknowledged state of the art, in order to enable
the provider of the high-risk AI system to fully comply with the obligations set out in this Regulation. This paragraph shall
not apply to third parties making accessible to the public tools, services, processes, or components, other than
general-purpose AI models, under a free and open-source licence.
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All parties must fully comply with the requirements outlined in this
Regulation. However, this does not apply to third parties that provide public access to tools, services, processes, or components, except for
general-purpose AI models, under a free and
open-source license.
The
AI Office may create and suggest optional contract terms for agreements between
providers of
high-risk AI systems and third parties that offer tools, services, components, or processes used in these systems. While developing these optional terms, the
AI Office will consider specific contractual needs relevant to different sectors or business cases. These terms will be published and made available for free in an easy-to-use electronic format.
Additionally, the requirements in paragraphs 2 and 3 do not affect the need to respect and protect
intellectual property rights,
confidential business information, and
trade secrets according to
Union and national laws.
Article 26: Responsibilities of
High-Risk AI System Deployers
1. Deployers of
high-risk AI systems must implement suitable technical and organizational measures to ensure the systems are used according to the provided instructions.
2. Deployers must designate qualified individuals to oversee the systems, ensuring they have the necessary skills, training, authority, and support.
3. The
obligations in paragraphs 1 and 2 do not interfere with other legal responsibilities of deployers under
Union or national law, nor do they limit the
deployer's ability to manage their resources and activities to fulfill the oversight requirements set by the
provider.
fully comply with the obligations set out in this Regulation. This paragraph shall
not apply to third parties making accessible to the public tools, services, processes, or components, other than
general-purpose AI models, under a free and open-source licence.
The AI Office may develop and recommend voluntary model terms for contracts between providers of high-risk AI systems
and third parties that supply tools, services, components or processes that are used for or integrated into high-risk AI
systems. When developing those voluntary model terms, the AI Office shall take into account possible contractual
requirements applicable in specific sectors or business cases. The voluntary model terms shall be published and be available
free of charge in an easily usable electronic format.
5.
Paragraphs 2 and 3 are without prejudice to the need to observe and protect intellectual property rights, confidential
business information and trade secrets in accordance with Union and national law.
Article 26
Obligations of deployers of high-risk AI systems
1.
Deployers of high-risk AI systems shall take appropriate technical and organisational measures to ensure they use
such systems in accordance with the instructions for use accompanying the systems, pursuant to paragraphs 3 and 6.
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2.
Deployers shall assign human oversight to natural persons who have the necessary competence, training and
authority, as well as the necessary support.
3.
The obligations set out in paragraphs 1 and 2, are without prejudice to other deployer obligations under Union or
national law and to the deployer’s freedom to organise its own resources and activities for the purpose of implementing the
human oversight measures indicated by the provider.
4.
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1 and 2, are without prejudice to other deployer obligations under Union or
national law and to the deployer’s freedom to organise its own resources and activities for the purpose of implementing the
human oversight measures indicated by the provider.
4.
Without prejudice to paragraphs 1 and 2, to the extent the deployer exercises control over the input data, that
deployer shall ensure that input data is relevant and sufficiently representative in view of the intended purpose of the
high-risk AI system.
5.
Deployers shall monitor the operation of the high-risk AI system on the basis of the instructions for use and, where
relevant, inform providers in accordance with Article 72. Where deployers have reason to consider that the use of the
high-risk AI system in accordance with the instructions may result in that AI system presenting a risk within the meaning of
Article 79(1), they shall, without undue delay, inform the provider or distributor and the relevant market surveillance
authority, and shall suspend the use of that system. Where deployers have identified a serious incident, they shall also
immediately inform first the provider, and then the importer or distributor and the relevant market surveillance authorities
of that incident. If the deployer is not able to reach the provider, Article 73 shall apply mutatis mutandis. This obligation
shall not cover sensitive operational data of deployers of AI systems which are law enforcement authorities.
For deployers that are financial institutions subject to requirements regarding their internal governance, arrangements or
processes under Union financial services law, the monitoring obligation set out in the first subparagraph shall be deemed to
be fulfilled by complying with the rules on internal governance arrangements, processes and mechanisms pursuant to the
relevant financial service law.
6.
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or
processes under Union financial services law, the monitoring obligation set out in the first subparagraph shall be deemed to
be fulfilled by complying with the rules on internal governance arrangements, processes and mechanisms pursuant to the
relevant financial service law.
6.
Deployers of high-risk AI systems shall keep the logs automatically generated by that high-risk AI system to the extent
such logs are under their control, for a period appropriate to the intended purpose of the high-risk AI system, of at least six
months, unless provided otherwise in applicable Union or national law, in particular in Union law on the protection of
personal data.
Deployers that are financial institutions subject to requirements regarding their internal governance, arrangements or
processes under Union financial services law shall maintain the logs as part of the documentation kept pursuant to the
relevant Union financial service law.
7.
Before putting into service or using a high-risk AI system at the workplace, deployers who are employers shall inform
workers’ representatives and the affected workers that they will be subject to the use of the high-risk AI system. This
information shall be provided, where applicable, in accordance with the rules and procedures laid down in Union and
national law and practice on information of workers and their representatives.
8.
Deployers of high-risk AI systems that are public authorities, or Union institutions, bodies, offices or agencies shall
comply with the registration obligations referred to in Article 49. When such deployers find that the high-risk AI system
that they envisage using has not been registered in the EU database referred to in Article 71, they shall not use that system
and shall inform the provider or the distributor.
9.
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When such deployers find that the high-risk AI system
that they envisage using has not been registered in the EU database referred to in Article 71, they shall not use that system
and shall inform the provider or the distributor.
9.
Where applicable, deployers of high-risk AI systems shall use the information provided under Article 13 of this
Regulation to comply with their obligation to carry out a data protection impact assessment under Article 35 of Regulation
(EU) 2016/679 or Article 27 of Directive (EU) 2016/680.
10.
Without prejudice to Directive (EU) 2016/680, in the framework of an investigation for the targeted search of
a person suspected or convicted of having committed a criminal offence, the deployer of a high-risk AI system for
post-remote biometric identification shall request an authorisation, ex ante, or without undue delay and no later than 48
hours, by a judicial authority or an administrative authority whose decision is binding and subject to judicial review, for the
use of that system, except when it is used for the initial identification of a potential suspect based on objective and verifiable
facts directly linked to the offence. Each use shall be limited to what is strictly necessary for the investigation of a specific
criminal offence.
If the authorisation requested pursuant to the first subparagraph is rejected, the use of the post-remote biometric
identification system linked to that requested authorisation shall be stopped with immediate effect and the personal data
linked to the use of the high-risk AI system for which the authorisation was requested shall be deleted.
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system linked to that requested authorisation shall be stopped with immediate effect and the personal data
linked to the use of the high-risk AI system for which the authorisation was requested shall be deleted.
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In no case shall such high-risk AI system for post-remote biometric identification be used for law enforcement purposes in
an untargeted way, without any link to a criminal offence, a criminal proceeding, a genuine and present or genuine and
foreseeable threat of a criminal offence, or the search for a specific missing person. It shall be ensured that no decision that
produces an adverse legal effect on a person may be taken by the law enforcement authorities based solely on the output of
such post-remote biometric identification systems.
This paragraph is without prejudice to Article 9 of Regulation (EU) 2016/679 and Article 10 of Directive (EU) 2016/680
for the processing of biometric data.
Regardless of the purpose or deployer, each use of such high-risk AI systems shall be documented in the relevant police file
and shall be made available to the relevant market surveillance authority and the national data protection authority upon
request, excluding the disclosure of sensitive operational data related to law enforcement. This subparagraph shall be
without prejudice to the powers conferred by Directive (EU) 2016/680 on supervisory authorities.
Deployers shall submit annual reports to the relevant market surveillance and national data protection authorities on their
use of post-remote biometric identification systems, excluding the disclosure of sensitive operational data related to law
enforcement. The reports may be aggregated to cover more than one deployment.
Member States may introduce, in accordance with Union law, more restrictive laws on the use of post-remote biometric
identification systems.
11.
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operational data related to law
enforcement. The reports may be aggregated to cover more than one deployment.
Member States may introduce, in accordance with Union law, more restrictive laws on the use of post-remote biometric
identification systems.
11.
Without prejudice to Article 50 of this Regulation, deployers of high-risk AI systems referred to in Annex III that
make decisions or assist in making decisions related to natural persons shall inform the natural persons that they are subject
to the use of the high-risk AI system. For high-risk AI systems used for law enforcement purposes Article 13 of Directive
(EU) 2016/680 shall apply.
12.
Deployers shall cooperate with the relevant competent authorities in any action those authorities take in relation to
the high-risk AI system in order to implement this Regulation.
Article 27
Fundamental rights impact assessment for high-risk AI systems
1.
Prior to deploying a high-risk AI system referred to in Article 6(2), with the exception of high-risk AI systems
intended to be used in the area listed in point 2 of Annex III, deployers that are bodies governed by public law, or are private
entities providing public services, and deployers of high-risk AI systems referred to in points 5 (b) and (c) of Annex III, shall
perform an assessment of the impact on fundamental rights that the use of such system may produce. For that purpose,
deployers shall perform an assessment consisting of:
(a) a description of the deployer’s processes in which the high-risk AI system will be used in line with its intended purpose;
(b) a description of the period of time within which, and the frequency with which, each high-risk AI system is intended to
be used;
(c) the categories of natural persons and groups likely to be affected by its use in the specific context;
(d) the specific risks of harm likely to have an impact on the categories of natural persons or
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The
high-risk AI system must be used in a specific way, and the following information is required: (a) how the
AI system is intended to be used; (b) the types of people and groups that may be affected by its use; (c) the specific risks of harm that could impact these people or groups, based on information provided by the supplier; (d) a description of how
human oversight will be implemented according to the usage instructions; (e) the actions to take if these risks occur, including internal governance and complaint procedures.
This requirement applies to the initial use of the
high-risk AI system. The
deployer can refer to previous assessments of
fundamental rights or existing assessments from the
provider in similar situations. If the
deployer finds that any of the information has changed or is outdated during the use of the
AI system, they must update it accordingly.
After completing the assessment, the
deployer must inform the
market surveillance authority of the results by submitting a completed template as part of the notification. In certain cases, as mentioned in Article 46(1), deployers may not need to notify.
-risk AI system is intended to
be used;
(c) the categories of natural persons and groups likely to be affected by its use in the specific context;
(d) the specific risks of harm likely to have an impact on the categories of natural persons or groups of persons identified
pursuant to point (c) of this paragraph, taking into account the information given by the provider pursuant to
Article 13;
(e) a description of the implementation of human oversight measures, according to the instructions for use;
(f) the measures to be taken in the case of the materialisation of those risks, including the arrangements for internal
governance and complaint mechanisms.
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2.
The obligation laid down in paragraph 1 applies to the first use of the high-risk AI system. The deployer may, in
similar cases, rely on previously conducted fundamental rights impact assessments or existing impact assessments carried
out by provider. If, during the use of the high-risk AI system, the deployer considers that any of the elements listed in
paragraph 1 has changed or is no longer up to date, the deployer shall take the necessary steps to update the information.
3.
Once the assessment referred to in paragraph 1 of this Article has been performed, the deployer shall notify the
market surveillance authority of its results, submitting the filled-out template referred to in paragraph 5 of this Article as
part of the notification. In the case referred to in Article 46(1), deployers may be exempt from that obligation to notify.
4.
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Deployers must submit a completed template mentioned in
paragraph 5 of this Article as part of their notification. However, as stated in Article 46(1), some deployers may not need to notify. If any
obligations in this Article are already fulfilled by a
data protection
impact assessment under
Article 35 of Regulation (EU) 2016/679 or
Article 27 of Directive (EU) 2016/680, the
fundamental rights impact assessment in paragraph 1 will add to that
data protection assessment. The
AI Office will create a questionnaire template, possibly using an automated tool, to help deployers meet their
obligations more easily.
SECTION 4
Notifying Authorities and
Notified Bodies
Article 28
Notifying Authorities
1. Each
Member State must appoint at least one
notifying authority to manage the procedures for assessing, designating, and notifying
conformity assessment bodies, as well as monitoring them. These procedures will be developed in collaboration with
notifying authorities from all
Member States.
2.
Member States can choose to have a national accreditation body, as defined by
Regulation (EC) No 765/2008, conduct the assessment and monitoring mentioned in paragraph 1.
3.
Notifying authorities must be structured and operated to avoid conflicts of interest with
conformity assessment bodies, ensuring their activities remain objective and impartial.
4. Decisions about notifying
conformity assessment bodies must be made by qualified individuals who did not conduct the assessments of those bodies.
of its results, submitting the filled-out template referred to in paragraph 5 of this Article as
part of the notification. In the case referred to in Article 46(1), deployers may be exempt from that obligation to notify.
4.
If any of the obligations laid down in this Article is already met through the data protection impact assessment
conducted pursuant to Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680, the fundamental
rights impact assessment referred to in paragraph 1 of this Article shall complement that data protection impact
assessment.
5.
The AI Office shall develop a template for a questionnaire, including through an automated tool, to facilitate deployers
in complying with their obligations under this Article in a simplified manner.
SECTION 4
Notifying authorities and notified bodies
Article 28
Notifying authorities
1.
Each Member State shall designate or establish at least one notifying authority responsible for setting up and carrying
out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their
monitoring. Those procedures shall be developed in cooperation between the notifying authorities of all Member States.
2.
Member States may decide that the assessment and monitoring referred to in paragraph 1 is to be carried out by
a national accreditation body within the meaning of, and in accordance with, Regulation (EC) No 765/2008.
3.
Notifying authorities shall be established, organised and operated in such a way that no conflict of interest arises with
conformity assessment bodies, and that the objectivity and impartiality of their activities are safeguarded.
4.
Notifying authorities shall be organised in such a way that decisions relating to the notification of conformity
assessment bodies are taken by competent persons different from those who carried out the assessment of those bodies.
5.
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ity of their activities are safeguarded.
4.
Notifying authorities shall be organised in such a way that decisions relating to the notification of conformity
assessment bodies are taken by competent persons different from those who carried out the assessment of those bodies.
5.
Notifying authorities shall offer or provide neither any activities that conformity assessment bodies perform, nor any
consultancy services on a commercial or competitive basis.
6.
Notifying authorities shall safeguard the confidentiality of the information that they obtain, in accordance with
Article 78.
7.
Notifying authorities shall have an adequate number of competent personnel at their disposal for the proper
performance of their tasks. Competent personnel shall have the necessary expertise, where applicable, for their function, in
fields such as information technologies, AI and law, including the supervision of fundamental rights.
Article 29
Application of a conformity assessment body for notification
1.
Conformity assessment bodies shall submit an application for notification to the notifying authority of the Member
State in which they are established.
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2.
The application for notification shall be accompanied by a description of the conformity assessment activities, the
conformity assessment module or modules and the types of AI systems for which the conformity assessment body claims
to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting
that the conformity assessment body fulfils the requirements laid down in Article 31.
Any valid document related to existing designations of the applicant notified body under any other Union harmonisation
legislation shall be added.
3.
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accreditation body attesting
that the conformity assessment body fulfils the requirements laid down in Article 31.
Any valid document related to existing designations of the applicant notified body under any other Union harmonisation
legislation shall be added.
3.
Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the
notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of
its compliance with the requirements laid down in Article 31.
4.
For notified bodies which are designated under any other Union harmonisation legislation, all documents and
certificates linked to those designations may be used to support their designation procedure under this Regulation, as
appropriate. The notified body shall update the documentation referred to in paragraphs 2 and 3 of this Article whenever
relevant changes occur, in order to enable the authority responsible for notified bodies to monitor and verify continuous
compliance with all the requirements laid down in Article 31.
Article 30
Notification procedure
1.
Notifying authorities may notify only conformity assessment bodies which have satisfied the requirements laid down
in Article 31.
2.
Notifying authorities shall notify the Commission and the other Member States, using the electronic notification tool
developed and managed by the Commission, of each conformity assessment body referred to in paragraph 1.
3.
The notification referred to in paragraph 2 of this Article shall include full details of the conformity assessment
activities, the conformity assessment module or modules, the types of AI systems concerned, and the relevant attestation of
competence. Where a notification is not based on an accreditation certificate as referred to in Article 29(2), the notifying
authority shall provide the Commission and the other Member States with documentary evidence which attests to the
competence of the conformity assessment body and to the arrangements in place to ensure that that body will be
monitored regularly and will continue to satisfy the requirements laid down in Article 31.
4.
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States with documentary evidence which attests to the
competence of the conformity assessment body and to the arrangements in place to ensure that that body will be
monitored regularly and will continue to satisfy the requirements laid down in Article 31.
4.
The conformity assessment body concerned may perform the activities of a notified body only where no objections
are raised by the Commission or the other Member States within two weeks of a notification by a notifying authority where
it includes an accreditation certificate referred to in Article 29(2), or within two months of a notification by the notifying
authority where it includes documentary evidence referred to in Article 29(3).
5.
Where objections are raised, the Commission shall, without delay, enter into consultations with the relevant Member
States and the conformity assessment body. In view thereof, the Commission shall decide whether the authorisation is
justified. The Commission shall address its decision to the Member State concerned and to the relevant conformity
assessment body.
Article 31
Requirements relating to notified bodies
1.
A notified body shall be established under the national law of a Member State and shall have legal personality.
2.
Notified bodies shall satisfy the organisational, quality management, resources and process requirements that are
necessary to fulfil their tasks, as well as suitable cybersecurity requirements.
3.
The organisational structure, allocation of responsibilities, reporting lines and operation of notified bodies shall
ensure confidence in their performance, and in the results of the conformity assessment activities that the notified bodies
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4.
Notified bodies shall be independent of the provider of a high-risk AI system in relation to which they perform
conformity assessment activities.
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Notified bodies must be independent from the
providers of
high-risk AI systems when conducting conformity assessments. They should also be free from any economic interests related to these systems and from competitors of the
providers. However, they can use
high-risk AI systems necessary for their operations or for personal use.
The management and staff of a
conformity assessment body must not be involved in designing, developing, marketing, or using
high-risk AI systems, nor should they represent those who are. They must avoid any activities that could compromise their independence or integrity in conformity assessments, especially consultancy services.
Notified bodies must be structured and operated to ensure their independence, objectivity, and impartiality. They need to have documented procedures to maintain impartiality and promote these principles within their organization and assessment activities.
Additionally,
notified bodies must have procedures to ensure that their personnel and associated bodies keep confidential any information they acquire during conformity assessments, unless disclosure is legally required.
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4.
Notified bodies shall be independent of the provider of a high-risk AI system in relation to which they perform
conformity assessment activities. Notified bodies shall also be independent of any other operator having an economic
interest in high-risk AI systems assessed, as well as of any competitors of the provider. This shall not preclude the use of
assessed high-risk AI systems that are necessary for the operations of the conformity assessment body, or the use of such
high-risk AI systems for personal purposes.
5.
Neither a conformity assessment body, its top-level management nor the personnel responsible for carrying out its
conformity assessment tasks shall be directly involved in the design, development, marketing or use of high-risk AI systems,
nor shall they represent the parties engaged in those activities. They shall not engage in any activity that might conflict with
their independence of judgement or integrity in relation to conformity assessment activities for which they are notified.
This shall, in particular, apply to consultancy services.
6.
Notified bodies shall be organised and operated so as to safeguard the independence, objectivity and impartiality of
their activities. Notified bodies shall document and implement a structure and procedures to safeguard impartiality and to
promote and apply the principles of impartiality throughout their organisation, personnel and assessment activities.
7.
Notified bodies shall have documented procedures in place ensuring that their personnel, committees, subsidiaries,
subcontractors and any associated body or personnel of external bodies maintain, in accordance with Article 78, the
confidentiality of the information which comes into their possession during the performance of conformity assessment
activities, except when its disclosure is required by law.
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Notified bodies and their staff must keep all information confidential that they receive while performing
conformity assessment activities, as stated in
Article 78. They can only disclose this information if required by law. Staff members are required to maintain professional secrecy regarding all information obtained during their work, except when communicating with the
notifying authorities of their
Member State.
Notified bodies must have procedures that consider the size, sector, structure, and complexity of the
AI systems they assess. They are also required to have appropriate liability insurance for their
conformity assessment activities, unless the
Member State assumes this liability according to
national law or is directly responsible for the assessment.
Notified bodies must perform their tasks with high professional integrity and the necessary expertise, whether they carry out these tasks themselves or through external parties. They should have enough internal expertise to effectively evaluate the work done by external parties on their behalf. This includes having a sufficient number of administrative, technical, legal, and scientific personnel with experience in relevant
AI systems and
data requirements.
Additionally,
notified bodies must participate in coordination activities as outlined in Article 38 and engage with European standardization organizations to stay informed about relevant standards.
ors and any associated body or personnel of external bodies maintain, in accordance with Article 78, the
confidentiality of the information which comes into their possession during the performance of conformity assessment
activities, except when its disclosure is required by law. The staff of notified bodies shall be bound to observe professional
secrecy with regard to all information obtained in carrying out their tasks under this Regulation, except in relation to the
notifying authorities of the Member State in which their activities are carried out.
8.
Notified bodies shall have procedures for the performance of activities which take due account of the size of
a provider, the sector in which it operates, its structure, and the degree of complexity of the AI system concerned.
9.
Notified bodies shall take out appropriate liability insurance for their conformity assessment activities, unless liability
is assumed by the Member State in which they are established in accordance with national law or that Member State is itself
directly responsible for the conformity assessment.
10.
Notified bodies shall be capable of carrying out all their tasks under this Regulation with the highest degree of
professional integrity and the requisite competence in the specific field, whether those tasks are carried out by notified
bodies themselves or on their behalf and under their responsibility.
11.
Notified bodies shall have sufficient internal competences to be able effectively to evaluate the tasks conducted by
external parties on their behalf. The notified body shall have permanent availability of sufficient administrative, technical,
legal and scientific personnel who possess experience and knowledge relating to the relevant types of AI systems, data and
data computing, and relating to the requirements set out in Section 2.
12.
Notified bodies shall participate in coordination activities as referred to in Article 38. They shall also take part
directly, or be represented in, European standardisation organisations, or ensure that they are aware and up to date in
respect of relevant standards.
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bodies shall participate in coordination activities as referred to in Article 38. They shall also take part
directly, or be represented in, European standardisation organisations, or ensure that they are aware and up to date in
respect of relevant standards.
Article 32
Presumption of conformity with requirements relating to notified bodies
Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised
standards or parts thereof, the references of which have been published in the Official Journal of the European Union, it shall
be presumed to comply with the requirements set out in Article 31 in so far as the applicable harmonised standards cover
those requirements.
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Article 33
Subsidiaries of notified bodies and subcontracting
1.
Where a notified body subcontracts specific tasks connected with the conformity assessment or has recourse to
a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements laid down in Article 31, and
shall inform the notifying authority accordingly.
2.
Notified bodies shall take full responsibility for the tasks performed by any subcontractors or subsidiaries.
3.
Activities may be subcontracted or carried out by a subsidiary only with the agreement of the provider. Notified
bodies shall make a list of their subsidiaries publicly available.
4.
The relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and
the work carried out by them under this Regulation shall be kept at the disposal of the notifying authority for a period of
five years from the termination date of the subcontracting.
Article 34
Operational obligations of notified bodies
1.
Notified bodies shall verify the conformity of high-risk AI systems in accordance with the conformity assessment
procedures set out in Article 43.
2.
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Termination date of the subcontracting.
**
Article 34: Responsibilities of
Notified Bodies**
1.
Notified bodies must check that
high-risk AI systems meet the required standards as outlined in
Article 43.
2. When carrying out their duties,
notified bodies should avoid placing unnecessary burdens on
providers. They should consider the
provider's size, industry, structure, and the complexity of the
high-risk AI system to reduce administrative and compliance costs, especially for micro and small enterprises as defined by
Recommendation 2003/361/EC. However, they must still maintain the necessary rigor and protection standards for compliance with this
Regulation.
3.
Notified bodies are required to provide all relevant documentation, including that from
providers, to the
notifying authority mentioned in
Article 28. This is to assist the authority in its assessment, designation, notification, and monitoring tasks.
**
Article 35: Identification Numbers and Lists of
Notified Bodies**
1. The
Commission will assign a unique identification number to each
notified body, even if a body is notified under multiple EU regulations.
2. The
Commission will publicly share a list of
notified bodies under this
Regulation, including their identification numbers and the activities they are authorized for, and will keep this list updated.
**
Article 36: Changes to Notifications**
1. The
notifying authority must inform the
Commission and other
Member States of any significant changes to a
notified body's status using the
electronic notification tool mentioned in
Article 30(2).
2. The procedures in
Articles 29 and 30 will also apply to any extensions of the notification's scope.
termination date of the subcontracting.
Article 34
Operational obligations of notified bodies
1.
Notified bodies shall verify the conformity of high-risk AI systems in accordance with the conformity assessment
procedures set out in Article 43.
2.
Notified bodies shall avoid unnecessary burdens for providers when performing their activities, and take due account
of the size of the provider, the sector in which it operates, its structure and the degree of complexity of the high-risk AI
system concerned, in particular in view of minimising administrative burdens and compliance costs for micro- and small
enterprises within the meaning of Recommendation 2003/361/EC. The notified body shall, nevertheless, respect the degree
of rigour and the level of protection required for the compliance of the high-risk AI system with the requirements of this
Regulation.
3.
Notified bodies shall make available and submit upon request all relevant documentation, including the providers’
documentation, to the notifying authority referred to in Article 28 to allow that authority to conduct its assessment,
designation, notification and monitoring activities, and to facilitate the assessment outlined in this Section.
Article 35
Identification numbers and lists of notified bodies
1.
The Commission shall assign a single identification number to each notified body, even where a body is notified under
more than one Union act.
2.
The Commission shall make publicly available the list of the bodies notified under this Regulation, including their
identification numbers and the activities for which they have been notified. The Commission shall ensure that the list is kept
up to date.
Article 36
Changes to notifications
1.
The notifying authority shall notify the Commission and the other Member States of any relevant changes to the
notification of a notified body via the electronic notification tool referred to in Article 30(2).
2.
The procedures laid down in Articles 29 and 30 shall apply to extensions of the scope of the notification.
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of any relevant changes to the
notification of a notified body via the electronic notification tool referred to in Article 30(2).
2.
The procedures laid down in Articles 29 and 30 shall apply to extensions of the scope of the notification.
For changes to the notification other than extensions of its scope, the procedures laid down in paragraphs (3) to (9) shall
apply.
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3.
Where a notified body decides to cease its conformity assessment activities, it shall inform the notifying authority and
the providers concerned as soon as possible and, in the case of a planned cessation, at least one year before ceasing its
activities. The certificates of the notified body may remain valid for a period of nine months after cessation of the notified
body’s activities, on condition that another notified body has confirmed in writing that it will assume responsibilities for the
high-risk AI systems covered by those certificates. The latter notified body shall complete a full assessment of the high-risk
AI systems affected by the end of that nine-month-period before issuing new certificates for those systems. Where the
notified body has ceased its activity, the notifying authority shall withdraw the designation.
4.
Where a notifying authority has sufficient reason to consider that a notified body no longer meets the requirements
laid down in Article 31, or that it is failing to fulfil its obligations, the notifying authority shall without delay investigate the
matter with the utmost diligence. In that context, it shall inform the notified body concerned about the objections raised
and give it the possibility to make its views known.
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If a
notified body is not meeting its
obligations, the
notifying authority must promptly investigate the issue. They will inform the
notified body about the concerns raised and allow it to respond. If the
notifying authority finds that the
notified body no longer meets the requirements in
Article 31 or is failing its
obligations, they can restrict, suspend, or withdraw its designation based on the severity of the issue. They must immediately notify the
Commission and other
Member States.
If a designation is suspended, restricted, or withdrawn, the
notified body must inform the affected
providers within 10 days. The
notifying authority will also ensure that the
notified body's files are maintained and accessible to other
Member States'
notifying authorities and
market surveillance authorities upon request.
When a designation is restricted, suspended, or withdrawn, the
notifying authority will:
(a) evaluate how this affects the
certificates issued by the
notified body;
(b) report their findings to the
Commission and other
Member States within three months of notifying the changes;
(c) require the
notified body to suspend or withdraw any improperly issued
certificates within a reasonable timeframe to ensure
high-risk AI systems remain compliant;
(d) inform the
Commission and
Member States about the
certificates that have been suspended or withdrawn;
(e) provide relevant information about the suspended or withdrawn
certificates to the
national authorities in the
Member State where the
provider is registered, so they can take appropriate action.
it is failing to fulfil its obligations, the notifying authority shall without delay investigate the
matter with the utmost diligence. In that context, it shall inform the notified body concerned about the objections raised
and give it the possibility to make its views known. If the notifying authority comes to the conclusion that the notified body
no longer meets the requirements laid down in Article 31 or that it is failing to fulfil its obligations, it shall restrict, suspend
or withdraw the designation as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil
those obligations. It shall immediately inform the Commission and the other Member States accordingly.
5.
Where its designation has been suspended, restricted, or fully or partially withdrawn, the notified body shall inform
the providers concerned within 10 days.
6.
In the event of the restriction, suspension or withdrawal of a designation, the notifying authority shall take
appropriate steps to ensure that the files of the notified body concerned are kept, and to make them available to notifying
authorities in other Member States and to market surveillance authorities at their request.
7.
In the event of the restriction, suspension or withdrawal of a designation, the notifying authority shall:
(a) assess the impact on the certificates issued by the notified body;
(b) submit a report on its findings to the Commission and the other Member States within three months of having notified
the changes to the designation;
(c) require the notified body to suspend or withdraw, within a reasonable period of time determined by the authority, any
certificates which were unduly issued, in order to ensure the continuing conformity of high-risk AI systems on the
market;
(d) inform the Commission and the Member States about certificates the suspension or withdrawal of which it has required;
(e) provide the national competent authorities of the Member State in which the provider has its registered place of
business with all relevant information about the certificates of which it has required the suspension or withdrawal; that
authority shall take the appropriate measures,
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required;
(e) provide the national competent authorities of the Member State in which the provider has its registered place of
business with all relevant information about the certificates of which it has required the suspension or withdrawal; that
authority shall take the appropriate measures, where necessary, to avoid a potential risk to health, safety or fundamental
rights.
8.
With the exception of certificates unduly issued, and where a designation has been suspended or restricted, the
certificates shall remain valid in one of the following circumstances:
(a) the notifying authority has confirmed, within one month of the suspension or restriction, that there is no risk to health,
safety or fundamental rights in relation to certificates affected by the suspension or restriction, and the notifying
authority has outlined a timeline for actions to remedy the suspension or restriction; or
(b) the notifying authority has confirmed that no certificates relevant to the suspension will be issued, amended or re-issued
during the course of the suspension or restriction, and states whether the notified body has the capability of continuing
to monitor and remain responsible for existing certificates issued for the period of the suspension or restriction; in the
event that the notifying authority determines that the notified body does not have the capability to support existing
certificates issued, the provider of the system covered by the certificate shall confirm in writing to the national
competent authorities of the Member State in which it has its registered place of business, within three months of the
suspension or restriction, that another qualified notified body is temporarily assuming the functions of the notified
body to monitor and remain responsible for the certificates during the period of suspension or restriction.
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9.
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certificates during the period of suspension or restriction.
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9.
With the exception of certificates unduly issued, and where a designation has been withdrawn, the certificates shall
remain valid for a period of nine months under the following circumstances:
(a) the national competent authority of the Member State in which the provider of the high-risk AI system covered by the
certificate has its registered place of business has confirmed that there is no risk to health, safety or fundamental rights
associated with the high-risk AI systems concerned; and
(b) another notified body has confirmed in writing that it will assume immediate responsibility for those AI systems and
completes its assessment within 12 months of the withdrawal of the designation.
In the circumstances referred to in the first subparagraph, the national competent authority of the Member State in which
the provider of the system covered by the certificate has its place of business may extend the provisional validity of the
certificates for additional periods of three months, which shall not exceed 12 months in total.
The national competent authority or the notified body assuming the functions of the notified body affected by the change
of designation shall immediately inform the Commission, the other Member States and the other notified bodies thereof.
Article 37
Challenge to the competence of notified bodies
1.
The Commission shall, where necessary, investigate all cases where there are reasons to doubt the competence of
a notified body or the continued fulfilment by a notified body of the requirements laid down in Article 31 and of its
applicable responsibilities.
2.
The notifying authority shall provide the Commission, on request, with all relevant information relating to the
notification or the maintenance of the competence of the notified body concerned.
3.
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laid down in Article 31 and of its
applicable responsibilities.
2.
The notifying authority shall provide the Commission, on request, with all relevant information relating to the
notification or the maintenance of the competence of the notified body concerned.
3.
The Commission shall ensure that all sensitive information obtained in the course of its investigations pursuant to this
Article is treated confidentially in accordance with Article 78.
4.
Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its
notification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures,
including the suspension or withdrawal of the notification if necessary. Where the Member State fails to take the necessary
corrective measures, the Commission may, by means of an implementing act, suspend, restrict or withdraw the designation.
That implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).
Article 38
Coordination of notified bodies
1.
The Commission shall ensure that, with regard to high-risk AI systems, appropriate coordination and cooperation
between notified bodies active in the conformity assessment procedures pursuant to this Regulation are put in place and
properly operated in the form of a sectoral group of notified bodies.
2.
Each notifying authority shall ensure that the bodies notified by it participate in the work of a group referred to in
paragraph 1, directly or through designated representatives.
3.
The Commission shall provide for the exchange of knowledge and best practices between notifying authorities.
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by it participate in the work of a group referred to in
paragraph 1, directly or through designated representatives.
3.
The Commission shall provide for the exchange of knowledge and best practices between notifying authorities.
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Article 39
Conformity assessment bodies of third countries
Conformity assessment bodies established under the law of a third country with which the Union has concluded an
agreement may be authorised to carry out the activities of notified bodies under this Regulation, provided that they meet
the requirements laid down in Article 31 or they ensure an equivalent level of compliance.
SECTION 5
Standards, conformity assessment, certificates, registration
Article 40
Harmonised standards and standardisation deliverables
1.
High-risk AI systems or general-purpose AI models which are in conformity with harmonised standards or parts
thereof the references of which have been published in the Official Journal of the European Union in accordance with
Regulation (EU) No 1025/2012 shall be presumed to be in conformity with the requirements set out in Section 2 of this
Chapter or, as applicable, with the obligations set out in of Chapter V, Sections 2 and 3, of this Regulation, to the extent that
those standards cover those requirements or obligations.
2.
In accordance with Article 10 of Regulation (EU) No 1025/2012, the Commission shall issue, without undue delay,
standardisation requests covering all requirements set out in Section 2 of this Chapter and, as applicable, standardisation
requests covering obligations set out in Chapter V, Sections 2 and 3, of this Regulation.
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The
Commission must quickly issue standardisation requests that cover all requirements in
Section 2 of this Chapter, as well as
obligations in
Chapter V, Sections 2 and 3 of this
Regulation. These requests should also include deliverables related to reporting and documentation processes aimed at improving the resource performance of
AI systems, such as reducing
energy consumption and other resource use during their lifecycle, and promoting energy-efficient development of
general-purpose AI models. The
Commission will consult the
Board and relevant
stakeholders, including the
advisory forum, when preparing these requests.
When sending standardisation requests to
European standardisation organisations, the
Commission will specify that the standards must be clear and consistent, aligning with existing
Union harmonisation legislation listed in
Annex I. The goal is to ensure that
high-risk AI systems or
general-purpose AI models available in the
Union meet the necessary requirements outlined in this
Regulation.
The
Commission will also ask
European standardisation organisations to demonstrate their efforts to achieve these objectives as per
Article 24 of
Regulation (EU) No 1025/2012.
Participants in the standardisation process should aim to encourage investment and innovation in
AI, enhance legal certainty, and boost the competitiveness and growth of the
Union market. This will help strengthen global cooperation on standardisation while considering existing international
AI standards that align with
Union values,
fundamental rights, and interests. Additionally, it will promote multi-stakeholder governance to ensure balanced representation and effective participation of all relevant
stakeholders, in accordance with Articles 5, 6, and 7 of
Regulation (EU) No.
issue, without undue delay,
standardisation requests covering all requirements set out in Section 2 of this Chapter and, as applicable, standardisation
requests covering obligations set out in Chapter V, Sections 2 and 3, of this Regulation. The standardisation request shall
also ask for deliverables on reporting and documentation processes to improve AI systems’ resource performance, such as
reducing the high-risk AI system’s consumption of energy and of other resources during its lifecycle, and on the
energy-efficient development of general-purpose AI models. When preparing a standardisation request, the Commission
shall consult the Board and relevant stakeholders, including the advisory forum.
When issuing a standardisation request to European standardisation organisations, the Commission shall specify that
standards have to be clear, consistent, including with the standards developed in the various sectors for products covered by
the existing Union harmonisation legislation listed in Annex I, and aiming to ensure that high-risk AI systems or
general-purpose AI models placed on the market or put into service in the Union meet the relevant requirements or
obligations laid down in this Regulation.
The Commission shall request the European standardisation organisations to provide evidence of their best efforts to fulfil
the objectives referred to in the first and the second subparagraph of this paragraph in accordance with Article 24 of
Regulation (EU) No 1025/2012.
3.
The participants in the standardisation process shall seek to promote investment and innovation in AI, including
through increasing legal certainty, as well as the competitiveness and growth of the Union market, to contribute to
strengthening global cooperation on standardisation and taking into account existing international standards in the field of
AI that are consistent with Union values, fundamental rights and interests, and to enhance multi-stakeholder governance
ensuring a balanced representation of interests and the effective participation of all relevant stakeholders in accordance with
Articles 5, 6, and 7 of Regulation (EU) No
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fundamental rights and interests, and to enhance multi-stakeholder governance
ensuring a balanced representation of interests and the effective participation of all relevant stakeholders in accordance with
Articles 5, 6, and 7 of Regulation (EU) No 1025/2012.
Article 41
Common specifications
1.
The Commission may adopt, implementing acts establishing common specifications for the requirements set out in
Section 2 of this Chapter or, as applicable, for the obligations set out in Sections 2 and 3 of Chapter V where the following
conditions have been fulfilled:
(a) the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European
standardisation organisations to draft a harmonised standard for the requirements set out in Section 2 of this Chapter,
or, as applicable, for the obligations set out in Sections 2 and 3 of Chapter V, and:
(i) the request has not been accepted by any of the European standardisation organisations; or
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(ii) the harmonised standards addressing that request are not delivered within the deadline set in accordance with
Article 10(1) of Regulation (EU) No 1025/2012; or
(iii) the relevant harmonised standards insufficiently address fundamental rights concerns; or
(iv) the harmonised standards do not comply with the request; and
(b) no reference to harmonised standards covering the requirements referred to in Section 2 of this Chapter or, as
applicable, the obligations referred to in Sections 2 and 3 of Chapter V has been published in the Official Journal of the
European Union in accordance with Regulation (EU) No 1025/2012, and no such reference is
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applicable, the obligations referred to in Sections 2 and 3 of Chapter V has been published in the Official Journal of the
European Union in accordance with Regulation (EU) No 1025/2012, and no such reference is expected to be published
within a reasonable period.
When drafting the common specifications, the Commission shall consult the advisory forum referred to in Article 67.
The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the
examination procedure referred to in Article 98(2).
2.
Before preparing a draft implementing act, the Commission shall inform the committee referred to in Article 22 of
Regulation (EU) No 1025/2012 that it considers the conditions laid down in paragraph 1 of this Article to be fulfilled.
3.
High-risk AI systems or general-purpose AI models which are in conformity with the common specifications referred
to in paragraph 1, or parts of those specifications, shall be presumed to be in conformity with the requirements set out in
Section 2 of this Chapter or, as applicable, to comply with the obligations referred to in Sections 2 and 3 of Chapter V, to
the extent those common specifications cover those requirements or those obligations.
4.
Where a harmonised standard is adopted by a European standardisation organisation and proposed to the
Commission for the publication of its reference in the Official Journal of the European Union, the Commission shall assess the
harmonised standard in accordance with Regulation (EU) No 1025/2012. When reference to a harmonised standard is
published in the Official Journal of the European Union, the Commission shall repeal the implementing acts referred to in
paragraph 1, or parts thereof which cover the same requirements set out in Section 2 of this Chapter or, as applicable, the
same obligations set out in Sections 2 and 3 of Chapter V.
5.
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acts referred to in
paragraph 1, or parts thereof which cover the same requirements set out in Section 2 of this Chapter or, as applicable, the
same obligations set out in Sections 2 and 3 of Chapter V.
5.
Where providers of high-risk AI systems or general-purpose AI models do not comply with the common
specifications referred to in paragraph 1, they shall duly justify that they have adopted technical solutions that meet the
requirements referred to in Section 2 of this Chapter or, as applicable, comply with the obligations set out in Sections 2 and
3 of Chapter V to a level at least equivalent thereto.
6.
Where a Member State considers that a common specification does not entirely meet the requirements set out in
Section 2 or, as applicable, comply with obligations set out in Sections 2 and 3 of Chapter V, it shall inform the
Commission thereof with a detailed explanation. The Commission shall assess that information and, if appropriate, amend
the implementing act establishing the common specification concerned.
Article 42
Presumption of conformity with certain requirements
1.
High-risk AI systems that have been trained and tested on data reflecting the specific geographical, behavioural,
contextual or functional setting within which they are intended to be used shall be presumed to comply with the relevant
requirements laid down in Article 10(4).
2.
High-risk AI systems that have been certified or for which a statement of conformity has been issued under
a cybersecurity scheme pursuant to Regulation (EU) 2019/881 and the references of which have been published in the
Official Journal of the European Union shall be presumed to comply with the cybersecurity requirements set out in Article 15
of this Regulation in so far as the cybersecurity certificate or statement of conformity or parts thereof cover those
requirements.
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the European Union shall be presumed to comply with the cybersecurity requirements set out in Article 15
of this Regulation in so far as the cybersecurity certificate or statement of conformity or parts thereof cover those
requirements.
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Article 43
Conformity assessment
1.
For high-risk AI systems listed in point 1 of Annex III, where, in demonstrating the compliance of a high-risk AI
system with the requirements set out in Section 2, the provider has applied harmonised standards referred to in Article 40,
or, where applicable, common specifications referred to in Article 41, the provider shall opt for one of the following
conformity assessment procedures based on:
(a) the internal control referred to in Annex VI; or
(b) the assessment of the quality management system and the assessment of the technical documentation, with the
involvement of a notified body, referred to in Annex VII.
In demonstrating the compliance of a high-risk AI system with the requirements set out in Section 2, the provider shall
follow the conformity assessment procedure set out in Annex VII where:
(a) harmonised standards referred to in Article 40 do not exist, and common specifications referred to in Article 41 are not
available;
(b) the provider has not applied, or has applied only part of, the harmonised standard;
(c) the common specifications referred to in point (a) exist, but the provider has not applied them;
(d) one or more of the harmonised standards referred to in point (a) has been published with a restriction, and only on the
part of the standard that was restricted.
For the purposes of the conformity assessment procedure referred to in Annex VII, the provider may choose any of the
notified bodies.
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Point (a) has been published with a restriction, specifically regarding the part of the standard that is restricted. For the
conformity assessment procedure mentioned in
Annex VII, the
provider can choose any
notified body. However, if the
high-risk AI system is to be used by
law enforcement, immigration, or
asylum authorities, or by
Union institutions, the
market surveillance authority mentioned in
Article 74(8) or (9) will act as the
notified body.
For
high-risk AI systems listed in points 2 to 8 of
Annex III,
providers must follow the
conformity assessment procedure based on internal control outlined in
Annex VI, which does not involve a
notified body.
For
high-risk AI systems that fall under the
Union harmonisation legislation in
Section A of Annex I,
providers must adhere to the relevant
conformity assessment procedures required by those laws. The requirements in
Section 2 of this Chapter will apply to these
high-risk AI systems and will be included in the assessment. Additionally, points 4.3, 4.4, 4.5, and the fifth paragraph of point 4.6 in
Annex VII will also apply.
Notified bodies that have been approved under these legal acts can assess the conformity of
high-risk AI systems with the requirements in
Section 2, provided that their compliance with the requirements in
Article 31(4), (5), (10), and (11) has been evaluated during the notification process under those legal acts.
point (a) has been published with a restriction, and only on the
part of the standard that was restricted.
For the purposes of the conformity assessment procedure referred to in Annex VII, the provider may choose any of the
notified bodies. However, where the high-risk AI system is intended to be put into service by law enforcement, immigration
or asylum authorities or by Union institutions, bodies, offices or agencies, the market surveillance authority referred to in
Article 74(8) or (9), as applicable, shall act as a notified body.
2.
For high-risk AI systems referred to in points 2 to 8 of Annex III, providers shall follow the conformity assessment
procedure based on internal control as referred to in Annex VI, which does not provide for the involvement of a notified
body.
3.
For high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I, the provider
shall follow the relevant conformity assessment procedure as required under those legal acts. The requirements set out in
Section 2 of this Chapter shall apply to those high-risk AI systems and shall be part of that assessment. Points 4.3., 4.4., 4.5.
and the fifth paragraph of point 4.6 of Annex VII shall also apply.
For the purposes of that assessment, notified bodies which have been notified under those legal acts shall be entitled to
control the conformity of the high-risk AI systems with the requirements set out in Section 2, provided that the compliance
of those notified bodies with requirements laid down in Article 31(4), (5), (10) and (11) has been assessed in the context of
the notification procedure under those legal acts.
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Section 2, provided that the compliance
of those notified bodies with requirements laid down in Article 31(4), (5), (10) and (11) has been assessed in the context of
the notification procedure under those legal acts.
Where a legal act listed in Section A of Annex I enables the product manufacturer to opt out from a third-party conformity
assessment, provided that that manufacturer has applied all harmonised standards covering all the relevant requirements,
that manufacturer may use that option only if it has also applied harmonised standards or, where applicable, common
specifications referred to in Article 41, covering all requirements set out in Section 2 of this Chapter.
4.
High-risk AI systems that have already been subject to a conformity assessment procedure shall undergo a new
conformity assessment procedure in the event of a substantial modification, regardless of whether the modified system is
intended to be further distributed or continues to be used by the current deployer.
For high-risk AI systems that continue to learn after being placed on the market or put into service, changes to the high-risk
AI system and its performance that have been pre-determined by the provider at the moment of the initial conformity
assessment and are part of the information contained in the technical documentation referred to in point 2(f) of Annex IV,
shall not constitute a substantial modification.
5.
The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annexes VI
and VII by updating them in light of technical progress.
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6.
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by updating them in light of technical progress.
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6.
The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend paragraphs 1
and 2 of this Article in order to subject high-risk AI systems referred to in points 2 to 8 of Annex III to the conformity
assessment procedure referred to in Annex VII or parts thereof. The Commission shall adopt such delegated acts taking into
account the effectiveness of the conformity assessment procedure based on internal control referred to in Annex VI in
preventing or minimising the risks to health and safety and protection of fundamental rights posed by such systems, as well
as the availability of adequate capacities and resources among notified bodies.
Article 44
Certificates
1.
Certificates issued by notified bodies in accordance with Annex VII shall be drawn-up in a language which can be
easily understood by the relevant authorities in the Member State in which the notified body is established.
2.
Certificates shall be valid for the period they indicate, which shall not exceed five years for AI systems covered by
Annex I, and four years for AI systems covered by Annex III. At the request of the provider, the validity of a certificate may
be extended for further periods, each not exceeding five years for AI systems covered by Annex I, and four years for AI
systems covered by Annex III, based on a re-assessment in accordance with the applicable conformity assessment
procedures. Any supplement to a certificate shall remain valid, provided that the certificate which it supplements is valid.
3.
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AI systems covered by
Annex III will have a validity period of four years,
subject to re-assessment based on the relevant
conformity assessment procedures. Any supplement to a certificate remains valid as long as the original certificate is valid.
If a
notified body determines that an
AI system no longer meets the requirements outlined in
Section 2, it may suspend or withdraw the certificate or impose restrictions. This action will consider proportionality unless the system
provider takes appropriate corrective action within a deadline set by the
notified body. The
notified body must provide reasons for its decision. There is an appeal process available for decisions made by
notified bodies, including those related to conformity
certificates.
Article 45 outlines the information
obligations of
notified bodies:
1.
Notified bodies must inform the
notifying authority about:
(a) any
Union technical documentation assessment certificates, supplements, and
quality management system approvals issued under
Annex VII;
(b) any refusals, restrictions, suspensions, or withdrawals of these
certificates or approvals;
(c) any changes affecting the scope or conditions of notification;
(d) any requests for information from
market surveillance authorities regarding
conformity assessment activities;
(e) upon request, details of
conformity assessment activities and other related activities, including cross-border and subcontracting work.
2. Each
notified body must inform other
notified bodies about:
(a)
quality management system approvals it has refused, suspended, or withdrawn, and provide approvals it has issued upon request;
(b)
Union technical documentation assessment certificates or supplements it has refused, withdrawn, suspended, or restricted, and provide details of issued
certificates or supplements upon request.
and four years for AI
systems covered by Annex III, based on a re-assessment in accordance with the applicable conformity assessment
procedures. Any supplement to a certificate shall remain valid, provided that the certificate which it supplements is valid.
3.
Where a notified body finds that an AI system no longer meets the requirements set out in Section 2, it shall, taking
account of the principle of proportionality, suspend or withdraw the certificate issued or impose restrictions on it, unless
compliance with those requirements is ensured by appropriate corrective action taken by the provider of the system within
an appropriate deadline set by the notified body. The notified body shall give reasons for its decision.
An appeal procedure against decisions of the notified bodies, including on conformity certificates issued, shall be available.
Article 45
Information obligations of notified bodies
1.
Notified bodies shall inform the notifying authority of the following:
(a) any Union technical documentation assessment certificates, any supplements to those certificates, and any quality
management system approvals issued in accordance with the requirements of Annex VII;
(b) any refusal, restriction, suspension or withdrawal of a Union technical documentation assessment certificate or a quality
management system approval issued in accordance with the requirements of Annex VII;
(c) any circumstances affecting the scope of or conditions for notification;
(d) any request for information which they have received from market surveillance authorities regarding conformity
assessment activities;
(e) on request, conformity assessment activities performed within the scope of their notification and any other activity
performed, including cross-border activities and subcontracting.
2.
Each notified body shall inform the other notified bodies of:
(a) quality management system approvals which it has refused, suspended or withdrawn, and, upon request, of quality
system approvals which it has issued;
(b) Union technical documentation assessment certificates or any supplements thereto which it has refused, withdrawn,
suspended or otherwise restricted, and, upon request, of the certificates and/or supplements thereto which it has issued.
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approvals which it has issued;
(b) Union technical documentation assessment certificates or any supplements thereto which it has refused, withdrawn,
suspended or otherwise restricted, and, upon request, of the certificates and/or supplements thereto which it has issued.
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3.
Each notified body shall provide the other notified bodies carrying out similar conformity assessment activities
covering the same types of AI systems with relevant information on issues relating to negative and, on request, positive
conformity assessment results.
4.
Notified bodies shall safeguard the confidentiality of the information that they obtain, in accordance with Article 78.
Article 46
Derogation from conformity assessment procedure
1.
By way of derogation from Article 43 and upon a duly justified request, any market surveillance authority may
authorise the placing on the market or the putting into service of specific high-risk AI systems within the territory of the
Member State concerned, for exceptional reasons of public security or the protection of life and health of persons,
environmental protection or the protection of key industrial and infrastructural assets. That authorisation shall be for
a limited period while the necessary conformity assessment procedures are being carried out, taking into account the
exceptional reasons justifying the derogation. The completion of those procedures shall be undertaken without undue delay.
2.
In a duly justified situation of urgency for exceptional reasons of public security or in the case of specific, substantial
and imminent threat to the life or physical safety of natural persons, law-enforcement authorities or civil protection
authorities may put a specific high-risk AI system into service without the authorisation referred to in paragraph 1,
provided that such authorisation is requested during or after the use without undue delay.
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persons, law-enforcement authorities or civil protection
authorities may put a specific high-risk AI system into service without the authorisation referred to in paragraph 1,
provided that such authorisation is requested during or after the use without undue delay. If the authorisation referred to in
paragraph 1 is refused, the use of the high-risk AI system shall be stopped with immediate effect and all the results and
outputs of such use shall be immediately discarded.
3.
The authorisation referred to in paragraph 1 shall be issued only if the market surveillance authority concludes that
the high-risk AI system complies with the requirements of Section 2. The market surveillance authority shall inform the
Commission and the other Member States of any authorisation issued pursuant to paragraphs 1 and 2. This obligation shall
not cover sensitive operational data in relation to the activities of law-enforcement authorities.
4.
Where, within 15 calendar days of receipt of the information referred to in paragraph 3, no objection has been raised
by either a Member State or the Commission in respect of an authorisation issued by a market surveillance authority of
a Member State in accordance with paragraph 1, that authorisation shall be deemed justified.
5.
Where, within 15 calendar days of receipt of the notification referred to in paragraph 3, objections are raised by
a Member State against an authorisation issued by a market surveillance authority of another Member State, or where the
Commission considers the authorisation to be contrary to Union law, or the conclusion of the Member States regarding the
compliance of the system as referred to in paragraph 3 to be unfounded, the Commission shall, without delay, enter into
consultations with the relevant Member State. The operators concerned shall be consulted and have the possibility to
present their views. Having regard thereto, the Commission shall decide whether the authorisation is justified.
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the Commission shall, without delay, enter into
consultations with the relevant Member State. The operators concerned shall be consulted and have the possibility to
present their views. Having regard thereto, the Commission shall decide whether the authorisation is justified. The
Commission shall address its decision to the Member State concerned and to the relevant operators.
6.
Where the Commission considers the authorisation unjustified, it shall be withdrawn by the market surveillance
authority of the Member State concerned.
7.
For high-risk AI systems related to products covered by Union harmonisation legislation listed in Section A of
Annex I, only the derogations from the conformity assessment established in that Union harmonisation legislation shall
apply.
Article 47
EU declaration of conformity
1.
The provider shall draw up a written machine readable, physical or electronically signed EU declaration of conformity
for each high-risk AI system, and keep it at the disposal of the national competent authorities for 10 years after the
high-risk AI system has been placed on the market or put into service. The EU declaration of conformity shall identify the
high-risk AI system for which it has been drawn up. A copy of the EU declaration of conformity shall be submitted to the
relevant national competent authorities upon request.
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2.
The EU declaration of conformity shall state that the high-risk AI system concerned meets the requirements set out in
Section 2. The EU declaration of conformity shall contain the information set out in Annex V, and shall be translated into
a language that can be easily understood by the national competent authorities of the Member States in which the high-risk
AI system is placed on the market or made available.
3.
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The information in
Annex V must be translated into a language that
national authorities in
Member States can easily understand when
high-risk AI systems are marketed or made available.
If
high-risk AI systems are also covered by other EU regulations that require a declaration of conformity, a single EU declaration will be created that addresses all relevant EU laws for that system. This declaration must include all necessary information to identify the applicable EU regulations.
By creating this EU declaration, the
provider takes responsibility for ensuring compliance with the requirements in
Section 2 and must keep the declaration updated as needed.
The
Commission has the authority to make changes to
Annex V, including updating the EU declaration content, to reflect necessary updates due to technical advancements.
Regarding
CE marking:
1. The
CE marking must follow the general principles outlined in
Article 30 of
Regulation (EC) No 765/2008.
2. For
high-risk AI systems offered digitally, a
digital CE marking should be used, accessible through the system's interface or via a machine-readable code or other electronic means.
3. The
CE marking must be clearly visible, legible, and permanent on
high-risk AI systems. If this is not feasible due to the system's nature, it should be placed on the packaging or accompanying documentation as appropriate.
contain the information set out in Annex V, and shall be translated into
a language that can be easily understood by the national competent authorities of the Member States in which the high-risk
AI system is placed on the market or made available.
3.
Where high-risk AI systems are subject to other Union harmonisation legislation which also requires an EU
declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all Union law applicable to
the high-risk AI system. The declaration shall contain all the information required to identify the Union harmonisation
legislation to which the declaration relates.
4.
By drawing up the EU declaration of conformity, the provider shall assume responsibility for compliance with the
requirements set out in Section 2. The provider shall keep the EU declaration of conformity up-to-date as appropriate.
5.
The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annex V by
updating the content of the EU declaration of conformity set out in that Annex, in order to introduce elements that become
necessary in light of technical progress.
Article 48
CE marking
1.
The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
2.
For high-risk AI systems provided digitally, a digital CE marking shall be used, only if it can easily be accessed via the
interface from which that system is accessed or via an easily accessible machine-readable code or other electronic means.
3.
The CE marking shall be affixed visibly, legibly and indelibly for high-risk AI systems. Where that is not possible or
not warranted on account of the nature of the high-risk AI system, it shall be affixed to the packaging or to the
accompanying documentation, as appropriate.
4.
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ibly for high-risk AI systems. Where that is not possible or
not warranted on account of the nature of the high-risk AI system, it shall be affixed to the packaging or to the
accompanying documentation, as appropriate.
4.
Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for
the conformity assessment procedures set out in Article 43. The identification number of the notified body shall be affixed
by the body itself or, under its instructions, by the provider or by the provider’s authorised representative. The identification
number shall also be indicated in any promotional material which mentions that the high-risk AI system fulfils the
requirements for CE marking.
5.
Where high-risk AI systems are subject to other Union law which also provides for the affixing of the CE marking, the
CE marking shall indicate that the high-risk AI system also fulfil the requirements of that other law.
Article 49
Registration
1.
Before placing on the market or putting into service a high-risk AI system listed in Annex III, with the exception of
high-risk AI systems referred to in point 2 of Annex III, the provider or, where applicable, the authorised representative
shall register themselves and their system in the EU database referred to in Article 71.
2.
Before placing on the market or putting into service an AI system for which the provider has concluded that it is not
high-risk according to Article 6(3), that provider or, where applicable, the authorised representative shall register
themselves and that system in the EU database referred to in Article 71.
3.
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The
provider has determined that it is not classified as high-risk under
Article 6(3). Therefore, the
provider or their authorized representative must register themselves and the system in the
EU database mentioned in
Article 71.
Before using or deploying a
high-risk AI system listed in
Annex III (except for those specified in point 2 of
Annex III),
public authorities, EU institutions, and individuals acting on their behalf must register themselves, select the system, and log its use in the
EU database referenced in
Article 71.
For
high-risk AI systems mentioned in points 1, 6, and 7 of
Annex III, which pertain to
law enforcement,
migration,
asylum, and border control, the registration must occur in a secure, non-public section of the
EU database. This registration will only include specific information as outlined in:
(a) Section A, points 1 to 10 of
Annex VIII, excluding points 6, 8, and 9;
(b) Section B, points 1 to 5, and points 8 and 9 of
Annex VIII;
(c) Section C, points 1 to 3 of
Annex VIII;
(d) points 1, 2, 3, and 5 of
Annex IX.
Only the
European Commission and the
national authorities specified in
Article 74(8) will have access to these restricted sections of the
EU database.
provider has concluded that it is not
high-risk according to Article 6(3), that provider or, where applicable, the authorised representative shall register
themselves and that system in the EU database referred to in Article 71.
3.
Before putting into service or using a high-risk AI system listed in Annex III, with the exception of high-risk AI
systems listed in point 2 of Annex III, deployers that are public authorities, Union institutions, bodies, offices or agencies or
persons acting on their behalf shall register themselves, select the system and register its use in the EU database referred to
in Article 71.
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4.
For high-risk AI systems referred to in points 1, 6 and 7 of Annex III, in the areas of law enforcement, migration,
asylum and border control management, the registration referred to in paragraphs 1, 2 and 3 of this Article shall be in
a secure non-public section of the EU database referred to in Article 71 and shall include only the following information, as
applicable, referred to in:
(a) Section A, points 1 to 10, of Annex VIII, with the exception of points 6, 8 and 9;
(b) Section B, points 1 to 5, and points 8 and 9 of Annex VIII;
(c) Section C, points 1 to 3, of Annex VIII;
(d) points 1, 2, 3 and 5, of Annex IX.
Only the Commission and national authorities referred to in Article 74(8) shall have access to the respective restricted
sections of the EU database listed in the first subparagraph of this paragraph.
5.
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Only the
Commission and specific
national authorities mentioned in
Article 74(8) can access the restricted sections of the
EU database outlined in
Annex IX.
High-risk AI systems, as described in point 2 of
Annex III, must be registered at the national level.
CHAPTER IV
TRANSPARENCY OBLIGATIONS FOR
PROVIDERS AND DEPLOYERS OF CERTAIN
AI SYSTEMS
Article 50
Transparency obligations for
providers and deployers of certain
AI systems
1.
Providers must ensure that
AI systems designed to interact directly with people inform them that they are engaging with an
AI system, unless it is clear to a reasonably informed and observant person based on the context. This requirement does not apply to
AI systems legally authorized to detect, prevent, investigate, or prosecute crimes, provided there are
safeguards for the rights of others, unless these systems are available for public reporting of crimes.
2.
Providers of
AI systems, including those that create synthetic audio, images, videos, or text, must mark the outputs in a machine-readable format to indicate they are artificially generated or altered.
Providers should ensure their
technical solutions are effective, compatible, robust, and reliable, considering the specific characteristics and limitations of different content types, implementation costs, and the current state of technology as reflected in relevant technical standards.
, 3 and 5, of Annex IX.
Only the Commission and national authorities referred to in Article 74(8) shall have access to the respective restricted
sections of the EU database listed in the first subparagraph of this paragraph.
5.
High-risk AI systems referred to in point 2 of Annex III shall be registered at national level.
CHAPTER IV
TRANSPARENCY OBLIGATIONS FOR PROVIDERS AND DEPLOYERS OF CERTAIN AI SYSTEMS
Article 50
Transparency obligations for providers and deployers of certain AI systems
1.
Providers shall ensure that AI systems intended to interact directly with natural persons are designed and developed in
such a way that the natural persons concerned are informed that they are interacting with an AI system, unless this is
obvious from the point of view of a natural person who is reasonably well-informed, observant and circumspect, taking
into account the circumstances and the context of use. This obligation shall not apply to AI systems authorised by law to
detect, prevent, investigate or prosecute criminal offences, subject to appropriate safeguards for the rights and freedoms of
third parties, unless those systems are available for the public to report a criminal offence.
2.
Providers of AI systems, including general-purpose AI systems, generating synthetic audio, image, video or text
content, shall ensure that the outputs of the AI system are marked in a machine-readable format and detectable as
artificially generated or manipulated. Providers shall ensure their technical solutions are effective, interoperable, robust and
reliable as far as this is technically feasible, taking into account the specificities and limitations of various types of content,
the costs of implementation and the generally acknowledged state of the art, as may be reflected in relevant technical
standards.
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AI systems should be reliable based on what is technically possible, considering the unique features and limitations of different types of content, the costs involved, and current technical standards. This requirement does not apply if the
AI systems are only assisting with standard editing, do not significantly change the input
data, or are legally authorized to help detect, prevent, investigate, or prosecute crimes.
Deployers of emotion recognition or biometric categorization systems must inform individuals about how these systems work and handle
personal data according to EU regulations (
Regulations (EU) 2016/679, (EU) 2018/1725, and
Directive (EU) 2016/680). However, this requirement does not apply to systems used for crime-related purposes, as long as there are
safeguards for the rights of others and compliance with EU law.
Deployers of
AI systems that create or alter images, audio, or video to produce
deep fakes must reveal that the content has been artificially created or modified. This requirement does not apply if the content is used legally for crime-related purposes. If the content is part of artistic, creative, satirical, fictional, or similar works, the obligation to disclose is limited to informing about the existence of such content in a way that does not interfere with the enjoyment of the work.
reliable as far as this is technically feasible, taking into account the specificities and limitations of various types of content,
the costs of implementation and the generally acknowledged state of the art, as may be reflected in relevant technical
standards. This obligation shall not apply to the extent the AI systems perform an assistive function for standard editing or
do not substantially alter the input data provided by the deployer or the semantics thereof, or where authorised by law to
detect, prevent, investigate or prosecute criminal offences.
3.
Deployers of an emotion recognition system or a biometric categorisation system shall inform the natural persons
exposed thereto of the operation of the system, and shall process the personal data in accordance with Regulations (EU)
2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680, as applicable. This obligation shall not apply to AI systems
used for biometric categorisation and emotion recognition, which are permitted by law to detect, prevent or investigate
criminal offences, subject to appropriate safeguards for the rights and freedoms of third parties, and in accordance with
Union law.
4.
Deployers of an AI system that generates or manipulates image, audio or video content constituting a deep fake, shall
disclose that the content has been artificially generated or manipulated. This obligation shall not apply where the use is
authorised by law to detect, prevent, investigate or prosecute criminal offence. Where the content forms part of an evidently
artistic, creative, satirical, fictional or analogous work or programme, the transparency obligations set out in this paragraph
are limited to disclosure of the existence of such generated or manipulated content in an appropriate manner that does not
hamper the display or enjoyment of the work.
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If a work or program is satirical, fictional, or similar, the rules about
transparency only require that the existence of any
AI-generated or manipulated content is disclosed in a way that does not interfere with the enjoyment of the work. Those who use an
AI system to create or alter text intended to inform the public must clearly state that the text is
AI-generated or manipulated. This requirement does not apply if the use is legally authorized for detecting, preventing, investigating, or prosecuting crimes, or if the
AI-generated content has been reviewed or edited by a human who is responsible for the publication.
The information mentioned must be provided to individuals in a clear and noticeable way at the time of their first interaction with the content, and it must meet accessibility standards.
These rules do not change any existing requirements in Chapter III or other
transparency laws at the
Union or national level for
AI system users. The
AI Office will promote and support the creation of
codes of practice at the
Union level to help implement the rules for detecting and labeling
AI-generated or manipulated content. The
Commission may approve these
codes of practice through specific procedures.
satirical, fictional or analogous work or programme, the transparency obligations set out in this paragraph
are limited to disclosure of the existence of such generated or manipulated content in an appropriate manner that does not
hamper the display or enjoyment of the work.
Deployers of an AI system that generates or manipulates text which is published with the purpose of informing the public
on matters of public interest shall disclose that the text has been artificially generated or manipulated. This obligation shall
not apply where the use is authorised by law to detect, prevent, investigate or prosecute criminal offences or where the
AI-generated content has undergone a process of human review or editorial control and where a natural or legal person
holds editorial responsibility for the publication of the content.
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5.
The information referred to in paragraphs 1 to 4 shall be provided to the natural persons concerned in a clear and
distinguishable manner at the latest at the time of the first interaction or exposure. The information shall conform to the
applicable accessibility requirements.
6.
Paragraphs 1 to 4 shall not affect the requirements and obligations set out in Chapter III, and shall be without
prejudice to other transparency obligations laid down in Union or national law for deployers of AI systems.
7.
The AI Office shall encourage and facilitate the drawing up of codes of practice at Union level to facilitate the effective
implementation of the obligations regarding the detection and labelling of artificially generated or manipulated content.
The Commission may adopt implementing acts to approve those codes of practice in accordance with the procedure laid
down in Article 56 (6).
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to facilitate the effective
implementation of the obligations regarding the detection and labelling of artificially generated or manipulated content.
The Commission may adopt implementing acts to approve those codes of practice in accordance with the procedure laid
down in Article 56 (6). If it deems the code is not adequate, the Commission may adopt an implementing act specifying
common rules for the implementation of those obligations in accordance with the examination procedure laid down in
Article 98(2).
CHAPTER V
GENERAL-PURPOSE AI MODELS
SECTION 1
Classification rules
Article 51
Classification of general-purpose AI models as general-purpose AI models with systemic risk
1.
A general-purpose AI model shall be classified as a general-purpose AI model with systemic risk if it meets any of the
following conditions:
(a) it has high impact capabilities evaluated on the basis of appropriate technical tools and methodologies, including
indicators and benchmarks;
(b) based on a decision of the Commission, ex officio or following a qualified alert from the scientific panel, it has
capabilities or an impact equivalent to those set out in point (a) having regard to the criteria set out in Annex XIII.
2.
A general-purpose AI model shall be presumed to have high impact capabilities pursuant to paragraph 1, point (a),
when the cumulative amount of computation used for its training measured in floating point operations is greater than
1025.
3.
The Commission shall adopt delegated acts in accordance with Article 97 to amend the thresholds listed in
paragraphs 1 and 2 of this Article, as well as to supplement benchmarks and indicators in light of evolving technological
developments, such as algorithmic improvements or increased hardware efficiency, when necessary, for these thresholds to
reflect the state of the art.
Article 52
Procedure
1.
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as well as to supplement benchmarks and indicators in light of evolving technological
developments, such as algorithmic improvements or increased hardware efficiency, when necessary, for these thresholds to
reflect the state of the art.
Article 52
Procedure
1.
Where a general-purpose AI model meets the condition referred to in Article 51(1), point (a), the relevant provider
shall notify the Commission without delay and in any event within two weeks after that requirement is met or it becomes
known that it will be met. That notification shall include the information necessary to demonstrate that the relevant
requirement has been met. If the Commission becomes aware of a general-purpose AI model presenting systemic risks of
which it has not been notified, it may decide to designate it as a model with systemic risk.
2.
The provider of a general-purpose AI model that meets the condition referred to in Article 51(1), point (a), may
present, with its notification, sufficiently substantiated arguments to demonstrate that, exceptionally, although it meets that
requirement, the general-purpose AI model does not present, due to its specific characteristics, systemic risks and therefore
should not be classified as a general-purpose AI model with systemic risk.
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3.
Where the Commission concludes that the arguments submitted pursuant to paragraph 2 are not sufficiently
substantiated and the relevant provider was not able to demonstrate that the general-purpose AI model does not present,
due to its specific characteristics, systemic risks, it shall reject those arguments, and the general-purpose AI model shall be
considered to be a general-purpose AI model with systemic risk.
4.
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that the general-purpose AI model does not present,
due to its specific characteristics, systemic risks, it shall reject those arguments, and the general-purpose AI model shall be
considered to be a general-purpose AI model with systemic risk.
4.
The Commission may designate a general-purpose AI model as presenting systemic risks, ex officio or following
a qualified alert from the scientific panel pursuant to Article 90(1), point (a), on the basis of criteria set out in Annex XIII.
The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annex XIII by
specifying and updating the criteria set out in that Annex.
5.
Upon a reasoned request of a provider whose model has been designated as a general-purpose AI model with systemic
risk pursuant to paragraph 4, the Commission shall take the request into account and may decide to reassess whether the
general-purpose AI model can still be considered to present systemic risks on the basis of the criteria set out in Annex XIII.
Such a request shall contain objective, detailed and new reasons that have arisen since the designation decision. Providers
may request reassessment at the earliest six months after the designation decision. Where the Commission, following its
reassessment, decides to maintain the designation as a general-purpose AI model with systemic risk, providers may request
reassessment at the earliest six months after that decision.
6.
The Commission shall ensure that a list of general-purpose AI models with systemic risk is published and shall keep
that list up to date, without prejudice to the need to observe and protect intellectual property rights and confidential
business information or trade secrets in accordance with Union and national law.
SECTION 2
Obligations for providers of general-purpose AI models
Article 53
Obligations for providers of general-purpose AI models
1.
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and confidential
business information or trade secrets in accordance with Union and national law.
SECTION 2
Obligations for providers of general-purpose AI models
Article 53
Obligations for providers of general-purpose AI models
1.
Providers of general-purpose AI models shall:
(a) draw up and keep up-to-date the technical documentation of the model, including its training and testing process and
the results of its evaluation, which shall contain, at a minimum, the information set out in Annex XI for the purpose of
providing it, upon request, to the AI Office and the national competent authorities;
(b) draw up, keep up-to-date and make available information and documentation to providers of AI systems who intend to
integrate the general-purpose AI model into their AI systems. Without prejudice to the need to observe and protect
intellectual property rights and confidential business information or trade secrets in accordance with Union and
national law, the information and documentation shall:
(i) enable providers of AI systems to have a good understanding of the capabilities and limitations of the
general-purpose AI model and to comply with their obligations pursuant to this Regulation; and
(ii) contain, at a minimum, the elements set out in Annex XII;
(c) put in place a policy to comply with Union law on copyright and related rights, and in particular to identify and comply
with, including through state-of-the-art technologies, a reservation of rights expressed pursuant to Article 4(3) of
Directive (EU) 2019/790;
(d) draw up and make publicly available a sufficiently detailed summary about the content used for training of the
general-purpose AI model, according to a template provided by the AI Office.
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2.
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According to a template from the
AI Office, the
obligations mentioned in paragraph 1, points (a) and (b), do not apply to
AI model providers who release their models under a free and
open-source license. This license must allow public access, usage, modification, and distribution of the model, and the model's
parameters, architecture, and usage information must be publicly available. However, this exception does not apply to
general-purpose AI models that pose
systemic risks.
Providers of
general-purpose AI models must cooperate with the
Commission and
national authorities as required by this
regulation. They can use
codes of practice, as defined in
Article 56, to show compliance with the
obligations in paragraph 1 until a standardized method is published. Following European harmonized standards will give
providers a presumption of compliance if those standards cover the
obligations. If
providers do not follow an approved code of practice or a European standard, they must find alternative ways to demonstrate compliance for the
Commission's assessment.
To help with compliance with
Annex XI, especially points 2 (d) and (e), the
Commission can create delegated acts under
Article 97 to specify measurement and calculation methods for consistent and verifiable documentation. Additionally, the
Commission can amend Annexes XI and XII through delegated acts as technology evolves.
to a template provided by the AI Office.
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2.
The obligations set out in paragraph 1, points (a) and (b), shall not apply to providers of AI models that are released
under a free and open-source licence that allows for the access, usage, modification, and distribution of the model, and
whose parameters, including the weights, the information on the model architecture, and the information on model usage,
are made publicly available. This exception shall not apply to general-purpose AI models with systemic risks.
3.
Providers of general-purpose AI models shall cooperate as necessary with the Commission and the national
competent authorities in the exercise of their competences and powers pursuant to this Regulation.
4.
Providers of general-purpose AI models may rely on codes of practice within the meaning of Article 56 to
demonstrate compliance with the obligations set out in paragraph 1 of this Article, until a harmonised standard is
published. Compliance with European harmonised standards grants providers the presumption of conformity to the extent
that those standards cover those obligations. Providers of general-purpose AI models who do not adhere to an approved
code of practice or do not comply with a European harmonised standard shall demonstrate alternative adequate means of
compliance for assessment by the Commission.
5.
For the purpose of facilitating compliance with Annex XI, in particular points 2 (d) and (e) thereof, the Commission is
empowered to adopt delegated acts in accordance with Article 97 to detail measurement and calculation methodologies
with a view to allowing for comparable and verifiable documentation.
6.
The Commission is empowered to adopt delegated acts in accordance with Article 97(2) to amend Annexes XI and XII
in light of evolving technological developments.
7.
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methodologies
with a view to allowing for comparable and verifiable documentation.
6.
The Commission is empowered to adopt delegated acts in accordance with Article 97(2) to amend Annexes XI and XII
in light of evolving technological developments.
7.
Any information or documentation obtained pursuant to this Article, including trade secrets, shall be treated in
accordance with the confidentiality obligations set out in Article 78.
Article 54
Authorised representatives of providers of general-purpose AI models
1.
Prior to placing a general-purpose AI model on the Union market, providers established in third countries shall, by
written mandate, appoint an authorised representative which is established in the Union.
2.
The provider shall enable its authorised representative to perform the tasks specified in the mandate received from the
provider.
3.
The authorised representative shall perform the tasks specified in the mandate received from the provider. It shall
provide a copy of the mandate to the AI Office upon request, in one of the official languages of the institutions of the
Union. For the purposes of this Regulation, the mandate shall empower the authorised representative to carry out the
following tasks:
(a) verify that the technical documentation specified in Annex XI has been drawn up and all obligations referred to in
Article 53 and, where applicable, Article 55 have been fulfilled by the provider;
(b) keep a copy of the technical documentation specified in Annex XI at the disposal of the AI Office and national
competent authorities, for a period of 10 years after the general-purpose AI model has been placed on the market, and
the contact details of the provider that appointed the authorised representative;
(c) provide the AI Office, upon a reasoned request, with all the information and documentation, including that referred to
in point (b), necessary to demonstrate compliance with the obligations in this Chapter;
(d) cooperate with the AI Office and competent authorities, upon a reasoned request, in any action they take in relation to
the general-purpose AI model
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Providers of
general-purpose AI models must demonstrate compliance with the
obligations outlined in this chapter. They are required to cooperate with the
AI Office and relevant authorities if requested, especially regarding actions related to the
AI model, including when it is used in
AI systems sold or operated in the
Union.
The authorized representative can be contacted by the
AI Office or authorities instead of the
provider for any compliance issues related to this
regulation.
If the authorized representative believes the
provider is not fulfilling its
obligations, they must terminate their
mandate and inform the
AI Office immediately, explaining the reasons for the termination.
However, this obligation does not apply to
providers of
general-purpose AI models that are released under a free and
open-source license, allowing access, use, modification, and distribution of the model, as long as the model's
parameters and architecture information are publicly available, unless these models pose
systemic risks.
that referred to
in point (b), necessary to demonstrate compliance with the obligations in this Chapter;
(d) cooperate with the AI Office and competent authorities, upon a reasoned request, in any action they take in relation to
the general-purpose AI model, including when the model is integrated into AI systems placed on the market or put into
service in the Union.
4.
The mandate shall empower the authorised representative to be addressed, in addition to or instead of the provider,
by the AI Office or the competent authorities, on all issues related to ensuring compliance with this Regulation.
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5.
The authorised representative shall terminate the mandate if it considers or has reason to consider the provider to be
acting contrary to its obligations pursuant to this Regulation. In such a case, it shall also immediately inform the AI Office
about the termination of the mandate and the reasons therefor.
6.
The obligation set out in this Article shall not apply to providers of general-purpose AI models that are released under
a free and open-source licence that allows for the access, usage, modification, and distribution of the model, and whose
parameters, including the weights, the information on the model architecture, and the information on model usage, are
made publicly available, unless the general-purpose AI models present systemic risks.
SECTION 3
Obligations of providers of general-purpose AI models with systemic risk
Article 55
Obligations of providers of general-purpose AI models with systemic risk
1.
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unless the general-purpose AI models present systemic risks.
SECTION 3
Obligations of providers of general-purpose AI models with systemic risk
Article 55
Obligations of providers of general-purpose AI models with systemic risk
1.
In addition to the obligations listed in Articles 53 and 54, providers of general-purpose AI models with systemic risk
shall:
(a) perform model evaluation in accordance with standardised protocols and tools reflecting the state of the art, including
conducting and documenting adversarial testing of the model with a view to identifying and mitigating systemic risks;
(b) assess and mitigate possible systemic risks at Union level, including their sources, that may stem from the development,
the placing on the market, or the use of general-purpose AI models with systemic risk;
(c) keep track of, document, and report, without undue delay, to the AI Office and, as appropriate, to national competent
authorities, relevant information about serious incidents and possible corrective measures to address them;
(d) ensure an adequate level of cybersecurity protection for the general-purpose AI model with systemic risk and the
physical infrastructure of the model.
2.
Providers of general-purpose AI models with systemic risk may rely on codes of practice within the meaning of
Article 56 to demonstrate compliance with the obligations set out in paragraph 1 of this Article, until a harmonised
standard is published. Compliance with European harmonised standards grants providers the presumption of conformity to
the extent that those standards cover those obligations. Providers of general-purpose AI models with systemic risks who do
not adhere to an approved code of practice or do not comply with a European harmonised standard shall demonstrate
alternative adequate means of compliance for assessment by the Commission.
3.
Any information or documentation obtained pursuant to this Article, including trade secrets, shall be treated in
accordance with the confidentiality obligations set out in Article 78.
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The standard must show alternative ways to comply for the
Commission's review. Any information or documents obtained under this Article, including
trade secrets, will be kept confidential as stated in
Article 78.
**SECTION 4:
Codes of Practice**
**
Article 56:
Codes of Practice**
1. The
AI Office will promote and support the creation of
codes of practice at the
Union level to help implement this
Regulation, considering international standards.
2. The
AI Office and the
Board will ensure that these
codes of practice address at least the requirements in
Articles 53 and 55, which include:
(a) Keeping the information mentioned in
Article 53(1), points (a) and (b), updated based on market and technology changes;
(b) Providing enough detail in the summary about the content used for training;
(c) Identifying
systemic risks at the
Union level, including their sources when relevant;
(d) Establishing measures and procedures for assessing and managing these
systemic risks, ensuring that documentation is proportional to the risks, considers their severity and likelihood, and addresses the specific challenges of managing these risks throughout the
AI value chain.
3. The
AI Office may invite all
providers of
general-purpose AI models and relevant
national authorities to help create these
codes of practice.
standard shall demonstrate
alternative adequate means of compliance for assessment by the Commission.
3.
Any information or documentation obtained pursuant to this Article, including trade secrets, shall be treated in
accordance with the confidentiality obligations set out in Article 78.
SECTION 4
Codes of practice
Article 56
Codes of practice
1.
The AI Office shall encourage and facilitate the drawing up of codes of practice at Union level in order to contribute
to the proper application of this Regulation, taking into account international approaches.
2.
The AI Office and the Board shall aim to ensure that the codes of practice cover at least the obligations provided for in
Articles 53 and 55, including the following issues:
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(a) the means to ensure that the information referred to in Article 53(1), points (a) and (b), is kept up to date in light of
market and technological developments;
(b) the adequate level of detail for the summary about the content used for training;
(c) the identification of the type and nature of the systemic risks at Union level, including their sources, where appropriate;
(d) the measures, procedures and modalities for the assessment and management of the systemic risks at Union level,
including the documentation thereof, which shall be proportionate to the risks, take into consideration their severity
and probability and take into account the specific challenges of tackling those risks in light of the possible ways in
which such risks may emerge and materialise along the AI value chain.
3.
The AI Office may invite all providers of general-purpose AI models, as well as relevant national competent
authorities, to participate in the drawing-up of codes of practice.
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The
AI Office will identify potential risks that may arise throughout the
AI value chain.
1. The
AI Office can invite all
providers of
general-purpose AI models and relevant
national authorities to help create
codes of practice. Civil society organizations, industry representatives, academic institutions, and other
stakeholders, including downstream
providers and independent experts, can also contribute to this process.
2. The
AI Office and the
Board will ensure that the
codes of practice clearly define their goals and include commitments or measures, such as
key performance indicators, to achieve these goals. They will consider the needs and interests of all
stakeholders, including affected individuals, at the
Union level.
3. The
AI Office will require participants in the
codes of practice to regularly report on how they are implementing their commitments and the results of those actions, including performance against key indicators. These indicators and reporting requirements will take into account the different sizes and capabilities of the participants.
4. The
AI Office and the
Board will continuously monitor and evaluate how well participants are meeting the objectives of the
codes of practice and their compliance with the relevant regulations. They will check if the codes meet the
obligations outlined in
Articles 53 and 55 and will publish their evaluations of the codes' effectiveness.
5. The
Commission can approve a code of practice through an implementing act, which will apply across the
Union. This act will follow the examination procedure specified in
Article 98(2).
6. The
AI Office may invite all
providers of
general-purpose AI models to follow the
codes of practice.
which such risks may emerge and materialise along the AI value chain.
3.
The AI Office may invite all providers of general-purpose AI models, as well as relevant national competent
authorities, to participate in the drawing-up of codes of practice. Civil society organisations, industry, academia and other
relevant stakeholders, such as downstream providers and independent experts, may support the process.
4.
The AI Office and the Board shall aim to ensure that the codes of practice clearly set out their specific objectives and
contain commitments or measures, including key performance indicators as appropriate, to ensure the achievement of
those objectives, and that they take due account of the needs and interests of all interested parties, including affected
persons, at Union level.
5.
The AI Office shall aim to ensure that participants to the codes of practice report regularly to the AI Office on the
implementation of the commitments and the measures taken and their outcomes, including as measured against the key
performance indicators as appropriate. Key performance indicators and reporting commitments shall reflect differences in
size and capacity between various participants.
6.
The AI Office and the Board shall regularly monitor and evaluate the achievement of the objectives of the codes of
practice by the participants and their contribution to the proper application of this Regulation. The AI Office and the Board
shall assess whether the codes of practice cover the obligations provided for in Articles 53 and 55, and shall regularly
monitor and evaluate the achievement of their objectives. They shall publish their assessment of the adequacy of the codes
of practice.
The Commission may, by way of an implementing act, approve a code of practice and give it a general validity within the
Union. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).
7.
The AI Office may invite all providers of general-purpose AI models to adhere to the codes of practice.
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The
AI Office will create a general rule for the
Union, following the examination procedure in
Article 98(2). It can invite all
providers of
general-purpose AI models to follow the
codes of practice. For those models that do not pose
systemic risks, adherence may only include the
obligations in
Article 53, unless they express interest in the full code. The
AI Office will also promote the review and update of these codes, especially as new standards emerge, and will help assess existing standards. The
codes of practice must be ready by May 2, 2025, and the
AI Office will take necessary actions, including inviting
providers as mentioned earlier. If the codes are not finalized by August 2, 2025, or if the
AI Office finds them inadequate, the
Commission may establish common rules for implementing the
obligations in
Articles 53 and 55 through implementing acts, following the procedure in
Article 98(2).
In Chapter VI,
Article 57 states that
Member States must ensure their authorities set up at least one
AI regulatory sandbox by August 2, 2026, which can be done in collaboration with authorities from other
Member States.
general validity within the
Union. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).
7.
The AI Office may invite all providers of general-purpose AI models to adhere to the codes of practice. For providers
of general-purpose AI models not presenting systemic risks this adherence may be limited to the obligations provided for in
Article 53, unless they declare explicitly their interest to join the full code.
8.
The AI Office shall, as appropriate, also encourage and facilitate the review and adaptation of the codes of practice, in
particular in light of emerging standards. The AI Office shall assist in the assessment of available standards.
9.
Codes of practice shall be ready at the latest by 2 May 2025. The AI Office shall take the necessary steps, including
inviting providers pursuant to paragraph 7.
If, by 2 August 2025, a code of practice cannot be finalised, or if the AI Office deems it is not adequate following its
assessment under paragraph 6 of this Article, the Commission may provide, by means of implementing acts, common rules
for the implementation of the obligations provided for in Articles 53 and 55, including the issues set out in paragraph 2 of
this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article
98(2).
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CHAPTER VI
MEASURES IN SUPPORT OF INNOVATION
Article 57
AI regulatory sandboxes
1.
Member States shall ensure that their competent authorities establish at least one AI regulatory sandbox at national
level, which shall be operational by 2 August 2026. That sandbox may also be established jointly with the competent
authorities of other Member States.
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Member States shall ensure that their competent authorities establish at least one AI regulatory sandbox at national
level, which shall be operational by 2 August 2026. That sandbox may also be established jointly with the competent
authorities of other Member States. The Commission may provide technical support, advice and tools for the establishment
and operation of AI regulatory sandboxes.
The obligation under the first subparagraph may also be fulfilled by participating in an existing sandbox in so far as that
participation provides an equivalent level of national coverage for the participating Member States.
2.
Additional AI regulatory sandboxes at regional or local level, or established jointly with the competent authorities of
other Member States may also be established.
3.
The European Data Protection Supervisor may also establish an AI regulatory sandbox for Union institutions, bodies,
offices and agencies, and may exercise the roles and the tasks of national competent authorities in accordance with this
Chapter.
4.
Member States shall ensure that the competent authorities referred to in paragraphs 1 and 2 allocate sufficient
resources to comply with this Article effectively and in a timely manner. Where appropriate, national competent authorities
shall cooperate with other relevant authorities, and may allow for the involvement of other actors within the AI ecosystem.
This Article shall not affect other regulatory sandboxes established under Union or national law. Member States shall ensure
an appropriate level of cooperation between the authorities supervising those other sandboxes and the national competent
authorities.
5.
AI regulatory sandboxes established under paragraph 1 shall provide for a controlled environment that fosters
innovation and facilitates the development, training, testing and validation of innovative AI systems for a limited time
before their being placed on the market or put into service pursuant to a specific sandbox plan agreed between the
providers or prospective providers and the competent authority. Such sandboxes may include testing in real world
conditions supervised therein.
6.
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Providers of
AI systems can test their products in a controlled environment, known as an
AI regulatory sandbox, before they are officially launched or used. This
sandbox is created through an agreement between the
providers and the relevant authority, allowing for real-world testing under supervision.
The
competent authorities will offer guidance, oversight, and support within the
sandbox to help identify risks, especially those related to
fundamental rights, health, and safety. They will also assess testing methods and their effectiveness in meeting the requirements of this
Regulation and other applicable laws.
Authorities will provide participating
providers with information on regulatory expectations and how to meet the
obligations outlined in this
Regulation. If requested, they will issue written proof of the activities completed in the
sandbox, along with an
exit report summarizing the activities and results.
Providers can use these documents to show compliance during the
conformity assessment process or market surveillance. The exit reports and written proof will be positively considered by
market surveillance authorities to speed up the
conformity assessment process.
With the
provider's consent and following confidentiality rules, the
Commission and the
Board can access the exit reports for their regulatory tasks. If both the
provider and the national authority agree, the
exit report may also be made publicly available through a designated information platform.
a limited time
before their being placed on the market or put into service pursuant to a specific sandbox plan agreed between the
providers or prospective providers and the competent authority. Such sandboxes may include testing in real world
conditions supervised therein.
6.
Competent authorities shall provide, as appropriate, guidance, supervision and support within the AI regulatory
sandbox with a view to identifying risks, in particular to fundamental rights, health and safety, testing, mitigation measures,
and their effectiveness in relation to the obligations and requirements of this Regulation and, where relevant, other Union
and national law supervised within the sandbox.
7.
Competent authorities shall provide providers and prospective providers participating in the AI regulatory sandbox
with guidance on regulatory expectations and how to fulfil the requirements and obligations set out in this Regulation.
Upon request of the provider or prospective provider of the AI system, the competent authority shall provide a written
proof of the activities successfully carried out in the sandbox. The competent authority shall also provide an exit report
detailing the activities carried out in the sandbox and the related results and learning outcomes. Providers may use such
documentation to demonstrate their compliance with this Regulation through the conformity assessment process or
relevant market surveillance activities. In this regard, the exit reports and the written proof provided by the national
competent authority shall be taken positively into account by market surveillance authorities and notified bodies, with
a view to accelerating conformity assessment procedures to a reasonable extent.
8.
Subject to the confidentiality provisions in Article 78, and with the agreement of the provider or prospective provider,
the Commission and the Board shall be authorised to access the exit reports and shall take them into account, as
appropriate, when exercising their tasks under this Regulation. If both the provider or prospective provider and the national
competent authority explicitly agree, the exit report may be made publicly available through the single information
platform referred to in this Article.
9.
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When carrying out their duties under this
Regulation, both the
provider (or potential
provider) and the national authority can agree to make the
exit report publicly available through the designated information platform mentioned in this Article.
The purpose of establishing
AI regulatory sandboxes is to achieve the following goals:
(a) Enhance legal clarity to ensure compliance with this
Regulation and other relevant
Union and national laws;
(b) Promote the sharing of best practices by collaborating with authorities involved in the
AI regulatory sandbox;
(c) Encourage innovation and competitiveness, and support the growth of an
AI ecosystem;
(d) Contribute to evidence-based regulatory learning;
(e) Facilitate and speed up access to the
Union market for
AI systems, especially those provided by small and medium-sized enterprises (
SMEs) and
start-ups.
National authorities must ensure that if
innovative AI systems involve
personal data processing or fall under the oversight of other authorities, the national
data protection authorities and relevant
competent authorities are included in the operation of the
AI regulatory sandbox and participate in supervising these aspects according to their roles and powers.
The
AI regulatory sandboxes will not interfere with the supervisory or corrective powers of the authorities overseeing them, including at regional or local levels. If significant health, safety, or
fundamental rights risks are identified during the development and testing of
AI systems, appropriate measures must be taken to address them.
National authorities have the authority to temporarily or permanently halt the testing process or participation in the
sandbox if effective mitigation is not possible, and they must inform the
AI Office of their decision.
appropriate, when exercising their tasks under this Regulation. If both the provider or prospective provider and the national
competent authority explicitly agree, the exit report may be made publicly available through the single information
platform referred to in this Article.
9.
The establishment of AI regulatory sandboxes shall aim to contribute to the following objectives:
(a) improving legal certainty to achieve regulatory compliance with this Regulation or, where relevant, other applicable
Union and national law;
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(b) supporting the sharing of best practices through cooperation with the authorities involved in the AI regulatory
sandbox;
(c) fostering innovation and competitiveness and facilitating the development of an AI ecosystem;
(d) contributing to evidence-based regulatory learning;
(e) facilitating and accelerating access to the Union market for AI systems, in particular when provided by SMEs, including
start-ups.
10.
National competent authorities shall ensure that, to the extent the innovative AI systems involve the processing of
personal data or otherwise fall under the supervisory remit of other national authorities or competent authorities providing
or supporting access to data, the national data protection authorities and those other national or competent authorities are
associated with the operation of the AI regulatory sandbox and involved in the supervision of those aspects to the extent of
their respective tasks and powers.
11.
The AI regulatory sandboxes shall not affect the supervisory or corrective powers of the competent authorities
supervising the sandboxes, including at regional or local level. Any significant risks to health and safety and fundamental
rights identified during the development and testing of such AI systems shall result in an adequate mitigation. National
competent authorities shall have the power to temporarily or permanently suspend the testing process, or the participation
in the sandbox if no effective mitigation is possible, and shall inform the AI Office of such decision.
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National authorities can temporarily or permanently stop the testing process or participation in the
AI regulatory sandbox if effective solutions are not found. They must inform the
AI Office of their decision. These authorities will use their legal powers to support
AI innovation in the
Union while following the law.
Providers in the
AI sandbox are responsible for any damage caused during their experiments. However, if they follow the rules and guidance from the national authority, they won't face administrative fines for breaking regulations. If other authorities were involved in supervising the
AI system and provided compliance guidance, no fines will be imposed for those laws either. The
AI sandboxes will be set up to encourage cooperation between
national authorities across borders.
National authorities will work together and coordinate their efforts through the
Board. They must inform the
AI Office and the
Board when a
sandbox is established and can request support. The
AI Office will maintain and publicly share a list of current and planned sandboxes to promote interaction and cooperation.
systems shall result in an adequate mitigation. National
competent authorities shall have the power to temporarily or permanently suspend the testing process, or the participation
in the sandbox if no effective mitigation is possible, and shall inform the AI Office of such decision. National competent
authorities shall exercise their supervisory powers within the limits of the relevant law, using their discretionary powers
when implementing legal provisions in respect of a specific AI regulatory sandbox project, with the objective of supporting
innovation in AI in the Union.
12.
Providers and prospective providers participating in the AI regulatory sandbox shall remain liable under applicable
Union and national liability law for any damage inflicted on third parties as a result of the experimentation taking place in
the sandbox. However, provided that the prospective providers observe the specific plan and the terms and conditions for
their participation and follow in good faith the guidance given by the national competent authority, no administrative fines
shall be imposed by the authorities for infringements of this Regulation. Where other competent authorities responsible for
other Union and national law were actively involved in the supervision of the AI system in the sandbox and provided
guidance for compliance, no administrative fines shall be imposed regarding that law.
13.
The AI regulatory sandboxes shall be designed and implemented in such a way that, where relevant, they facilitate
cross-border cooperation between national competent authorities.
14.
National competent authorities shall coordinate their activities and cooperate within the framework of the Board.
15.
National competent authorities shall inform the AI Office and the Board of the establishment of a sandbox, and may
ask them for support and guidance. The AI Office shall make publicly available a list of planned and existing sandboxes and
keep it up to date in order to encourage more interaction in the AI regulatory sandboxes and cross-border cooperation.
16.
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The
AI Office will provide a public list of both planned and existing
AI regulatory sandboxes, keeping it updated to promote interaction and cooperation across borders.
National authorities must submit
annual reports to the
AI Office and the
Board starting one year after the
sandbox is established, and continue doing so each year until it ends, along with a final report. These reports will detail the progress and outcomes of the sandboxes, including best practices, incidents, lessons learned, and recommendations for their setup and potential revisions to the
regulation. The
national authorities will also make these reports or summaries available online for the public. The
Commission will consider these
annual reports when fulfilling its responsibilities under this
regulation. Additionally, the
Commission will create a single interface that contains all relevant information about
AI regulatory sandboxes, allowing
stakeholders to interact with them, ask questions to the authorities, and seek informal guidance on compliance for innovative
AI-related products and services. The
Commission will coordinate with
national authorities as needed.
may
ask them for support and guidance. The AI Office shall make publicly available a list of planned and existing sandboxes and
keep it up to date in order to encourage more interaction in the AI regulatory sandboxes and cross-border cooperation.
16.
National competent authorities shall submit annual reports to the AI Office and to the Board, from one year after
the establishment of the AI regulatory sandbox and every year thereafter until its termination, and a final report. Those
reports shall provide information on the progress and results of the implementation of those sandboxes, including best
practices, incidents, lessons learnt and recommendations on their setup and, where relevant, on the application and possible
revision of this Regulation, including its delegated and implementing acts, and on the application of other Union law
supervised by the competent authorities within the sandbox. The national competent authorities shall make those annual
reports or abstracts thereof available to the public, online. The Commission shall, where appropriate, take the annual
reports into account when exercising its tasks under this Regulation.
17.
The Commission shall develop a single and dedicated interface containing all relevant information related to AI
regulatory sandboxes to allow stakeholders to interact with AI regulatory sandboxes and to raise enquiries with competent
authorities, and to seek non-binding guidance on the conformity of innovative products, services, business models
embedding AI technologies, in accordance with Article 62(1), point (c). The Commission shall proactively coordinate with
national competent authorities, where relevant.
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Article 58
Detailed arrangements for, and functioning of, AI regulatory sandboxes
1.
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In 2024, the
European Commission will create rules for
AI regulatory sandboxes to ensure consistency across the EU. These rules will cover: (a) criteria for who can participate in the
sandbox; (b) the application process, monitoring, and how to exit the
sandbox; and (c) the terms for participants. The
Commission will adopt these rules following a specific examination process.
The rules will ensure that: (a) anyone who meets the eligibility criteria can apply, and
national authorities must inform applicants of their decision within three months; (b) the sandboxes will be accessible to all and can accommodate demand, allowing partnerships with other relevant parties; (c)
national authorities have the flexibility to manage their sandboxes; (d) participation is free for small and medium-sized enterprises (
SMEs) and
start-ups, although some costs may be recovered; and (e) the sandboxes will help participants learn and comply with regulations.
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Article 58
Detailed arrangements for, and functioning of, AI regulatory sandboxes
1.
In order to avoid fragmentation across the Union, the Commission shall adopt implementing acts specifying the
detailed arrangements for the establishment, development, implementation, operation and supervision of the AI regulatory
sandboxes. The implementing acts shall include common principles on the following issues:
(a) eligibility and selection criteria for participation in the AI regulatory sandbox;
(b) procedures for the application, participation, monitoring, exiting from and termination of the AI regulatory sandbox,
including the sandbox plan and the exit report;
(c) the terms and conditions applicable to the participants.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
2.
The implementing acts referred to in paragraph 1 shall ensure:
(a) that AI regulatory sandboxes are open to any applying provider or prospective provider of an AI system who fulfils
eligibility and selection criteria, which shall be transparent and fair, and that national competent authorities inform
applicants of their decision within three months of the application;
(b) that AI regulatory sandboxes allow broad and equal access and keep up with demand for participation; providers and
prospective providers may also submit applications in partnerships with deployers and other relevant third parties;
(c) that the detailed arrangements for, and conditions concerning AI regulatory sandboxes support, to the best extent
possible, flexibility for national competent authorities to establish and operate their AI regulatory sandboxes;
(d) that access to the AI regulatory sandboxes is free of charge for SMEs, including start-ups, without prejudice to
exceptional costs that national competent authorities may recover in a fair and proportionate manner;
(e) that they facilitate providers and prospective providers, by means of the learning outcomes of the AI regulatory
sandboxes, in complying
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Start-ups can recover exceptional costs fairly and proportionately.
AI regulatory sandboxes help
providers and potential
providers meet compliance requirements under this
Regulation and follow the voluntary
codes of conduct mentioned in Article 95. These sandboxes also encourage collaboration among various
stakeholders in the
AI ecosystem, including
notified bodies, standardization organizations, small and medium-sized enterprises (
SMEs),
start-ups, innovators, testing facilities, research labs,
European Digital Innovation Hubs, centers of excellence, and individual researchers, to foster cooperation between public and private sectors. The application, selection, participation, and exit processes for the
AI regulatory sandbox should be simple, clear, and easy to understand, making it easier for
SMEs and
start-ups with limited legal and administrative resources to participate. These processes should be consistent across the EU to prevent fragmentation, ensuring that participation in a
sandbox established by a
Member State or the
European Data Protection Supervisor is recognized uniformly and has the same legal implications throughout the
Union. Participation in the
AI regulatory sandbox should be limited to a timeframe that suits the project's complexity and scale, with the possibility of extension by the national authority. Additionally,
AI regulatory sandboxes should support the creation of tools and infrastructure for testing, benchmarking, assessing, and explaining important aspects of
AI systems, such as
accuracy,
robustness, and
cybersecurity, as well as measures to mitigate risks to
fundamental rights and society.
start-ups, without prejudice to
exceptional costs that national competent authorities may recover in a fair and proportionate manner;
(e) that they facilitate providers and prospective providers, by means of the learning outcomes of the AI regulatory
sandboxes, in complying with conformity assessment obligations under this Regulation and the voluntary application
of the codes of conduct referred to in Article 95;
(f) that AI regulatory sandboxes facilitate the involvement of other relevant actors within the AI ecosystem, such as notified
bodies and standardisation organisations, SMEs, including start-ups, enterprises, innovators, testing and experimenta
tion facilities, research and experimentation labs and European Digital Innovation Hubs, centres of excellence,
individual researchers, in order to allow and facilitate cooperation with the public and private sectors;
(g) that procedures, processes and administrative requirements for application, selection, participation and exiting the AI
regulatory sandbox are simple, easily intelligible, and clearly communicated in order to facilitate the participation of
SMEs, including start-ups, with limited legal and administrative capacities and are streamlined across the Union, in order
to avoid fragmentation and that participation in an AI regulatory sandbox established by a Member State, or by the
European Data Protection Supervisor is mutually and uniformly recognised and carries the same legal effects across the
Union;
(h) that participation in the AI regulatory sandbox is limited to a period that is appropriate to the complexity and scale of
the project and that may be extended by the national competent authority;
(i) that AI regulatory sandboxes facilitate the development of tools and infrastructure for testing, benchmarking, assessing
and explaining dimensions of AI systems relevant for regulatory learning, such as accuracy, robustness and
cybersecurity, as well as measures to mitigate risks to fundamental rights and society at large.
3.
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The
AI regulatory framework includes systems for testing and evaluating
AI technologies, focusing on important aspects like
accuracy, reliability, and
cybersecurity. It also aims to address risks to
fundamental rights and society. Small and medium-sized enterprises (
SMEs) and
start-ups participating in
AI regulatory sandboxes will receive guidance on how to implement these regulations, along with access to services that help with standardization, certification, testing, and innovation hubs.
National authorities can allow real-world testing within these sandboxes, but they must agree on the testing conditions and
safeguards to protect
fundamental rights and public safety. They should also work together to ensure consistent practices across the
European Union.
In the
AI regulatory sandbox,
personal data that has been legally collected for other purposes can be used to develop, train, and test
AI systems, provided that these systems are aimed at serving a significant
public interest. This includes areas like public safety and health, such as disease detection and healthcare improvement.
and infrastructure for testing, benchmarking, assessing
and explaining dimensions of AI systems relevant for regulatory learning, such as accuracy, robustness and
cybersecurity, as well as measures to mitigate risks to fundamental rights and society at large.
3.
Prospective providers in the AI regulatory sandboxes, in particular SMEs and start-ups, shall be directed, where
relevant, to pre-deployment services such as guidance on the implementation of this Regulation, to other value-adding
services such as help with standardisation documents and certification, testing and experimentation facilities, European
Digital Innovation Hubs and centres of excellence.
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4.
Where national competent authorities consider authorising testing in real world conditions supervised within the
framework of an AI regulatory sandbox to be established under this Article, they shall specifically agree the terms and
conditions of such testing and, in particular, the appropriate safeguards with the participants, with a view to protecting
fundamental rights, health and safety. Where appropriate, they shall cooperate with other national competent authorities
with a view to ensuring consistent practices across the Union.
Article 59
Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory
sandbox
1.
In the AI regulatory sandbox, personal data lawfully collected for other purposes may be processed solely for the
purpose of developing, training and testing certain AI systems in the sandbox when all of the following conditions are met:
(a) AI systems shall be developed for safeguarding substantial public interest by a public authority or another natural or
legal person and in one or more of the following areas:
(i) public safety and public health, including disease detection, diagnosis prevention, control and treatment and
improvement of health care systems;
(ii) a high level of protection and improvement of the quality of
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The following areas are covered: (i) public safety and health, including disease detection, diagnosis, prevention, control, treatment, and improving healthcare systems; (ii) enhancing environmental quality, protecting biodiversity, reducing pollution, and addressing climate change; (iii) ensuring energy sustainability; (iv) improving the safety and resilience of transportation systems and
critical infrastructure; (v) increasing the efficiency and quality of public administration and services. Additionally: (b) the
data used must be necessary to meet specific requirements that cannot be fulfilled with anonymized or non-
personal data; (c) there must be effective monitoring to identify and address any high risks to individuals' rights during the
sandbox testing, with mechanisms to mitigate these risks; (d)
personal data must be processed in a secure, isolated environment controlled by the
provider, with access limited to authorized personnel; (e)
data can only be shared according to EU
data protection laws, and
personal data from the
sandbox cannot be shared outside of it; (f) processing
personal data in the
sandbox should not affect individuals' rights or lead to decisions impacting them; (g)
personal data must be protected with appropriate measures and deleted after the
sandbox participation ends.
in one or more of the following areas:
(i) public safety and public health, including disease detection, diagnosis prevention, control and treatment and
improvement of health care systems;
(ii) a high level of protection and improvement of the quality of the environment, protection of biodiversity, protection
against pollution, green transition measures, climate change mitigation and adaptation measures;
(iii) energy sustainability;
(iv) safety and resilience of transport systems and mobility, critical infrastructure and networks;
(v) efficiency and quality of public administration and public services;
(b) the data processed are necessary for complying with one or more of the requirements referred to in Chapter III,
Section 2 where those requirements cannot effectively be fulfilled by processing anonymised, synthetic or other
non-personal data;
(c) there are effective monitoring mechanisms to identify if any high risks to the rights and freedoms of the data subjects, as
referred to in Article 35 of Regulation (EU) 2016/679 and in Article 39 of Regulation (EU) 2018/1725, may arise
during the sandbox experimentation, as well as response mechanisms to promptly mitigate those risks and, where
necessary, stop the processing;
(d) any personal data to be processed in the context of the sandbox are in a functionally separate, isolated and protected
data processing environment under the control of the prospective provider and only authorised persons have access to
those data;
(e) providers can further share the originally collected data only in accordance with Union data protection law; any
personal data created in the sandbox cannot be shared outside the sandbox;
(f) any processing of personal data in the context of the sandbox neither leads to measures or decisions affecting the data
subjects nor does it affect the application of their rights laid down in Union law on the protection of personal data;
(g) any personal data processed in the context of the sandbox are protected by means of appropriate technical and
organisational measures and deleted once the participation in the sandbox has
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Individuals can exercise their rights under
Union law regarding
personal data protection. Any
personal data used in the
sandbox will be safeguarded with appropriate technical and organizational measures and will be deleted once participation ends or the
data retention period expires.
Logs of
personal data processing in the
sandbox will be maintained for the duration of participation, unless otherwise specified by
Union or national law. A detailed description of the training, testing, and validation process for the
AI system, along with testing results, will be included in the
technical documentation as outlined in
Annex IV. A brief summary of the
AI project, its goals, and expected outcomes will be published on the
competent authorities' website, excluding
sensitive operational data related to
law enforcement, border control, immigration, or
asylum activities. For the prevention, investigation, detection, or prosecution of crimes, or for enforcing criminal penalties, the processing of
personal data in
AI regulatory sandboxes will be governed by specific
Union or national laws and must meet the same conditions mentioned earlier.
application of their rights laid down in Union law on the protection of personal data;
(g) any personal data processed in the context of the sandbox are protected by means of appropriate technical and
organisational measures and deleted once the participation in the sandbox has terminated or the personal data has
reached the end of its retention period;
(h) the logs of the processing of personal data in the context of the sandbox are kept for the duration of the participation in
the sandbox, unless provided otherwise by Union or national law;
(i) a complete and detailed description of the process and rationale behind the training, testing and validation of the AI
system is kept together with the testing results as part of the technical documentation referred to in Annex IV;
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(j) a short summary of the AI project developed in the sandbox, its objectives and expected results is published on the
website of the competent authorities; this obligation shall not cover sensitive operational data in relation to the activities
of law enforcement, border control, immigration or asylum authorities.
2.
For the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of
criminal penalties, including safeguarding against and preventing threats to public security, under the control and
responsibility of law enforcement authorities, the processing of personal data in AI regulatory sandboxes shall be based on
a specific Union or national law and subject to the same cumulative conditions as referred to in paragraph 1.
3.
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Law enforcement authorities are responsible for processing
personal data in
AI regulatory sandboxes, which must follow specific
Union or national laws and meet certain conditions. This does not affect laws that restrict the use of
personal data for purposes not explicitly stated, nor does it impact laws that allow
data processing necessary for developing, testing, or training
innovative AI systems, as long as they comply with
Union data protection laws.
Article 60 discusses the testing of
high-risk AI systems in real-world conditions outside of
AI regulatory sandboxes.
Providers of these systems, listed in
Annex III, can conduct testing according to a
real-world testing plan, while still adhering to the prohibitions outlined in
Article 5. The
Commission will define the details of this testing plan through implementing acts, following the examination procedure in
Article 98(2). This testing must also comply with any relevant
Union or national laws regarding
high-risk AI systems related to products covered by
Union harmonization legislation in
Annex I.
Providers can test their
high-risk AI systems in real-world conditions at any time before they are marketed or put into service, either independently or in collaboration with others. Additionally, this testing must still comply with any ethical reviews required by
Union or national law.
under the control and
responsibility of law enforcement authorities, the processing of personal data in AI regulatory sandboxes shall be based on
a specific Union or national law and subject to the same cumulative conditions as referred to in paragraph 1.
3.
Paragraph 1 is without prejudice to Union or national law which excludes processing of personal data for other
purposes than those explicitly mentioned in that law, as well as to Union or national law laying down the basis for the
processing of personal data which is necessary for the purpose of developing, testing or training of innovative AI systems or
any other legal basis, in compliance with Union law on the protection of personal data.
Article 60
Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes
1.
Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes may be conducted by
providers or prospective providers of high-risk AI systems listed in Annex III, in accordance with this Article and the
real-world testing plan referred to in this Article, without prejudice to the prohibitions under Article 5.
The Commission shall, by means of implementing acts, specify the detailed elements of the real-world testing plan. Those
implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
This paragraph shall be without prejudice to Union or national law on the testing in real world conditions of high-risk AI
systems related to products covered by Union harmonisation legislation listed in Annex I.
2.
Providers or prospective providers may conduct testing of high-risk AI systems referred to in Annex III in real world
conditions at any time before the placing on the market or the putting into service of the AI system on their own or in
partnership with one or more deployers or prospective deployers.
3.
The testing of high-risk AI systems in real world conditions under this Article shall be without prejudice to any ethical
review that is required by Union or national law.
4.
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partnership with one or more deployers or prospective deployers.
3.
The testing of high-risk AI systems in real world conditions under this Article shall be without prejudice to any ethical
review that is required by Union or national law.
4.
Providers or prospective providers may conduct the testing in real world conditions only where all of the following
conditions are met:
(a) the provider or prospective provider has drawn up a real-world testing plan and submitted it to the market surveillance
authority in the Member State where the testing in real world conditions is to be conducted;
(b) the market surveillance authority in the Member State where the testing in real world conditions is to be conducted has
approved the testing in real world conditions and the real-world testing plan; where the market surveillance authority
has not provided an answer within 30 days, the testing in real world conditions and the real-world testing plan shall be
understood to have been approved; where national law does not provide for a tacit approval, the testing in real world
conditions shall remain subject to an authorisation;
(c) the provider or prospective provider, with the exception of providers or prospective providers of high-risk AI systems
referred to in points 1, 6 and 7 of Annex III in the areas of law enforcement, migration, asylum and border control
management, and high-risk AI systems referred to in point 2 of Annex III has registered the testing in real world
conditions in accordance with Article 71(4) with a Union-wide unique single identification number and with the
information specified in Annex IX; the provider or prospective provider of high-risk AI systems referred to in points 1,
6 and 7 of Annex III in the areas of law enforcement, migration, asylum and border control management, has registered
the testing in real-world conditions in the secure non-public section of the EU database according to Article 49(4), point
(d), with a Union-wide unique single identification number and with
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The management of
migration,
asylum, and border control has recorded the testing of
high-risk AI systems in real-world conditions within a secure, non-public section of the
EU database, as outlined in
Article 49(4)(d). This includes a unique identification number and the required information.
Providers of these
AI systems must also register their real-world testing according to
Article 49(5).
Key points include:
(d) The
provider or potential
provider conducting the testing must be based in the EU or have a legal representative in the EU.
(e)
Data collected during testing can only be shared with third countries if proper
safeguards under EU law are in place.
(f) Testing should not exceed six months, although it can be extended for another six months with prior notification to the
market surveillance authority, including a justification for the extension.
(g) Individuals from
vulnerable groups, such as those with disabilities or the elderly, must be adequately protected during testing.
(h) If the testing involves collaboration with other organizations, they must be informed about all relevant aspects of the testing and receive instructions on using the
AI system. An agreement must be established between the
provider and the collaborating organizations to clarify their roles and responsibilities.
, migration, asylum and border control management, has registered
the testing in real-world conditions in the secure non-public section of the EU database according to Article 49(4), point
(d), with a Union-wide unique single identification number and with the information specified therein; the provider or
prospective provider of high-risk AI systems referred to in point 2 of Annex III has registered the testing in real-world
conditions in accordance with Article 49(5);
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(d) the provider or prospective provider conducting the testing in real world conditions is established in the Union or has
appointed a legal representative who is established in the Union;
(e) data collected and processed for the purpose of the testing in real world conditions shall be transferred to third
countries only provided that appropriate and applicable safeguards under Union law are implemented;
(f) the testing in real world conditions does not last longer than necessary to achieve its objectives and in any case not
longer than six months, which may be extended for an additional period of six months, subject to prior notification by
the provider or prospective provider to the market surveillance authority, accompanied by an explanation of the need
for such an extension;
(g) the subjects of the testing in real world conditions who are persons belonging to vulnerable groups due to their age or
disability, are appropriately protected;
(h) where a provider or prospective provider organises the testing in real world conditions in cooperation with one or more
deployers or prospective deployers, the latter have been informed of all aspects of the testing that are relevant to their
decision to participate, and given the relevant instructions for use of the AI system referred to in Article 13; the
provider or prospective provider and the deployer or prospective deployer shall conclude an agreement specifying their
roles and responsibilities with
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Before participating in the
AI system testing, both the
provider (or potential
provider) and the
deployer (or potential
deployer) must sign an agreement that outlines their roles and responsibilities. This ensures they comply with testing regulations and other relevant laws. The following conditions must be met: (i) Participants in the testing must give
informed consent as per
Article 61. If obtaining consent is not possible for
law enforcement purposes, the testing must not harm the participants, and their
personal data must be deleted after the test. (j) The testing must be supervised by qualified individuals from both the
provider and
deployer who have the necessary training and authority. (k) The
AI system's predictions, recommendations, or decisions must be reversible and can be ignored. Participants or their legal representatives can withdraw from the testing at any time without penalty, simply by revoking their consent, and they can request the immediate deletion of their
personal data. This withdrawal does not affect any actions already taken. According to Article 75,
Member States must empower their
market surveillance authorities to require information from
providers, conduct unannounced inspections, and check the testing of
high-risk AI systems.
to their
decision to participate, and given the relevant instructions for use of the AI system referred to in Article 13; the
provider or prospective provider and the deployer or prospective deployer shall conclude an agreement specifying their
roles and responsibilities with a view to ensuring compliance with the provisions for testing in real world conditions
under this Regulation and under other applicable Union and national law;
(i) the subjects of the testing in real world conditions have given informed consent in accordance with Article 61, or in the
case of law enforcement, where the seeking of informed consent would prevent the AI system from being tested, the
testing itself and the outcome of the testing in the real world conditions shall not have any negative effect on the
subjects, and their personal data shall be deleted after the test is performed;
(j) the testing in real world conditions is effectively overseen by the provider or prospective provider, as well as by
deployers or prospective deployers through persons who are suitably qualified in the relevant field and have the
necessary capacity, training and authority to perform their tasks;
(k) the predictions, recommendations or decisions of the AI system can be effectively reversed and disregarded.
5.
Any subjects of the testing in real world conditions, or their legally designated representative, as appropriate, may,
without any resulting detriment and without having to provide any justification, withdraw from the testing at any time by
revoking their informed consent and may request the immediate and permanent deletion of their personal data. The
withdrawal of the informed consent shall not affect the activities already carried out.
6.
In accordance with Article 75, Member States shall confer on their market surveillance authorities the powers of
requiring providers and prospective providers to provide information, of carrying out unannounced remote or on-site
inspections, and of performing checks on the conduct of the testing in real world conditions and the related high-risk AI
systems.
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powers of
requiring providers and prospective providers to provide information, of carrying out unannounced remote or on-site
inspections, and of performing checks on the conduct of the testing in real world conditions and the related high-risk AI
systems. Market surveillance authorities shall use those powers to ensure the safe development of testing in real world
conditions.
7.
Any serious incident identified in the course of the testing in real world conditions shall be reported to the national
market surveillance authority in accordance with Article 73. The provider or prospective provider shall adopt immediate
mitigation measures or, failing that, shall suspend the testing in real world conditions until such mitigation takes place, or
otherwise terminate it. The provider or prospective provider shall establish a procedure for the prompt recall of the AI
system upon such termination of the testing in real world conditions.
8.
Providers or prospective providers shall notify the national market surveillance authority in the Member State where
the testing in real world conditions is to be conducted of the suspension or termination of the testing in real world
conditions and of the final outcomes.
9.
The provider or prospective provider shall be liable under applicable Union and national liability law for any damage
caused in the course of their testing in real world conditions.
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Article 61
Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes
1.
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Article 61 outlines the requirements for obtaining
informed consent from individuals participating in real-world testing of
AI systems, as specified in
Article 60. Before participating, individuals must be given clear and understandable information about: (a) the purpose of the testing and any potential inconveniences; (b) the conditions of the testing, including how long it will last; (c) their rights, including the right to refuse or withdraw from the testing at any time without penalty; (d) how to request changes to the
AI system's predictions or decisions; and (e) the unique identification number for the testing and contact information for the
provider. The consent must be documented with a date, and a copy must be provided to the participants or their legal representatives.
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Article 61
Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes
1.
For the purpose of testing in real world conditions under Article 60, freely-given informed consent shall be obtained
from the subjects of testing prior to their participation in such testing and after their having been duly informed with
concise, clear, relevant, and understandable information regarding:
(a) the nature and objectives of the testing in real world conditions and the possible inconvenience that may be linked to
their participation;
(b) the conditions under which the testing in real world conditions is to be conducted, including the expected duration of
the subject or subjects’ participation;
(c) their rights, and the guarantees regarding their participation, in particular their right to refuse to participate in, and the
right to withdraw from, testing in real world conditions at any time without any resulting detriment and without having
to provide any justification;
(d) the arrangements for requesting the reversal or the disregarding of the predictions, recommendations or decisions of
the AI system;
(e) the Union-wide unique single identification number of the testing in real world conditions in accordance with Article
60(4) point (c), and the contact details of the provider or its legal representative from whom further information can be
obtained.
2.
The informed consent shall be dated and documented and a copy shall be given to the subjects of testing or their legal
representative.
Article 62
Measures for providers and deployers, in particular SMEs, including start-ups
1.
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Informed consent must be dated and documented, and a copy should be given to the participants or their legal representatives.
**
Article 62: Support for
Providers and Deployers, Especially
SMEs and
Start-ups**
1.
Member States must take the following actions:
(a) Give priority access to
AI regulatory sandboxes for
SMEs and
start-ups with a registered office or branch in the EU, as long as they meet eligibility criteria. Other
SMEs and
start-ups can also access the sandboxes if they meet the same criteria.
(b) Organize training and awareness programs about this
Regulation specifically for
SMEs,
start-ups, deployers, and relevant local
public authorities.
(c) Use existing communication channels and create new ones to provide advice and answer questions for
SMEs,
start-ups, deployers, and local
public authorities regarding this
Regulation and participation in
AI regulatory sandboxes.
(d) Help
SMEs and other
stakeholders take part in the standardization development process.
2. When setting fees for conformity assessments under
Article 43, the specific needs of SME
providers and
start-ups will be considered, and fees will be reduced based on their size, market size, and other relevant factors.
3. The
AI Office will:
(a) Provide standardized templates for areas covered by this
Regulation as requested by the
Board.
(b) Create and maintain a single information platform that offers easy-to-understand information about this
Regulation for all operators in the EU.
.
The informed consent shall be dated and documented and a copy shall be given to the subjects of testing or their legal
representative.
Article 62
Measures for providers and deployers, in particular SMEs, including start-ups
1.
Member States shall undertake the following actions:
(a) provide SMEs, including start-ups, having a registered office or a branch in the Union, with priority access to the AI
regulatory sandboxes, to the extent that they fulfil the eligibility conditions and selection criteria; the priority access
shall not preclude other SMEs, including start-ups, other than those referred to in this paragraph from access to the AI
regulatory sandbox, provided that they also fulfil the eligibility conditions and selection criteria;
(b) organise specific awareness raising and training activities on the application of this Regulation tailored to the needs of
SMEs including start-ups, deployers and, as appropriate, local public authorities;
(c) utilise existing dedicated channels and where appropriate, establish new ones for communication with SMEs including
start-ups, deployers, other innovators and, as appropriate, local public authorities to provide advice and respond to
queries about the implementation of this Regulation, including as regards participation in AI regulatory sandboxes;
(d) facilitate the participation of SMEs and other relevant stakeholders in the standardisation development process.
2.
The specific interests and needs of the SME providers, including start-ups, shall be taken into account when setting the
fees for conformity assessment under Article 43, reducing those fees proportionately to their size, market size and other
relevant indicators.
3.
The AI Office shall undertake the following actions:
(a) provide standardised templates for areas covered by this Regulation, as specified by the Board in its request;
(b) develop and maintain a single information platform providing easy to use information in relation to this Regulation for
all operators across the Union;
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The
Board has requested the following actions regarding this
Regulation:
(b) Create and maintain a user-friendly information platform for all operators in the
Union to access information related to this
Regulation.
(c) Launch communication campaigns to inform people about their
obligations under this
Regulation.
(d) Assess and promote the adoption of best practices in public procurement procedures for
AI systems.
Article 63: Exceptions for Specific Operators
1.
Microenterprises, as defined by
Recommendation 2003/361/EC, can meet some parts of the
quality management system required by
Article 17 of this
Regulation in a simpler way, as long as they do not have partner or linked enterprises. The
Commission will provide guidelines on which parts of the
quality management system can be simplified for
microenterprises, ensuring that safety and compliance with
high-risk AI system requirements are still maintained.
2. This simplification does not exempt these operators from meeting other requirements or
obligations outlined in this
Regulation, including those in Articles 9, 10, 11, 12, 13, 14, 15, 72, and 73.
CHAPTER VII: GOVERNANCE
SECTION 1: Governance at
Union Level
Article 64:
AI Office
1. The
Commission will build expertise and capabilities in
AI through the
AI Office.
2.
Member States will support the
AI Office in carrying out its tasks as described in this
Regulation.
Article 65: Establishment and Structure of the
European Artificial Intelligence Board
this Regulation, as specified by the Board in its request;
(b) develop and maintain a single information platform providing easy to use information in relation to this Regulation for
all operators across the Union;
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(c) organise appropriate communication campaigns to raise awareness about the obligations arising from this Regulation;
(d) evaluate and promote the convergence of best practices in public procurement procedures in relation to AI systems.
Article 63
Derogations for specific operators
1.
Microenterprises within the meaning of Recommendation 2003/361/EC may comply with certain elements of the
quality management system required by Article 17 of this Regulation in a simplified manner, provided that they do not
have partner enterprises or linked enterprises within the meaning of that Recommendation. For that purpose, the
Commission shall develop guidelines on the elements of the quality management system which may be complied with in
a simplified manner considering the needs of microenterprises, without affecting the level of protection or the need for
compliance with the requirements in respect of high-risk AI systems.
2.
Paragraph 1 of this Article shall not be interpreted as exempting those operators from fulfilling any other
requirements or obligations laid down in this Regulation, including those established in Articles 9, 10, 11, 12, 13, 14, 15,
72 and 73.
CHAPTER VII
GOVERNANCE
SECTION 1
Governance at Union level
Article 64
AI Office
1.
The Commission shall develop Union expertise and capabilities in the field of AI through the AI Office.
2.
Member States shall facilitate the tasks entrusted to the AI Office, as reflected in this Regulation.
Article 65
Establishment and structure of the European Artificial Intelligence Board
1.
Show original text
expertise and capabilities in the field of AI through the AI Office.
2.
Member States shall facilitate the tasks entrusted to the AI Office, as reflected in this Regulation.
Article 65
Establishment and structure of the European Artificial Intelligence Board
1.
A European Artificial Intelligence Board (the ‘Board’) is hereby established.
2.
The Board shall be composed of one representative per Member State. The European Data Protection Supervisor shall
participate as observer. The AI Office shall also attend the Board’s meetings, without taking part in the votes. Other national
and Union authorities, bodies or experts may be invited to the meetings by the Board on a case by case basis, where the
issues discussed are of relevance for them.
3.
Each representative shall be designated by their Member State for a period of three years, renewable once.
4.
Member States shall ensure that their representatives on the Board:
(a) have the relevant competences and powers in their Member State so as to contribute actively to the achievement of the
Board’s tasks referred to in Article 66;
(b) are designated as a single contact point vis-à-vis the Board and, where appropriate, taking into account Member States’
needs, as a single contact point for stakeholders;
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(c) are empowered to facilitate consistency and coordination between national competent authorities in their Member State
as regards the implementation of this Regulation, including through the collection of relevant data and information for
the purpose of fulfilling their tasks on the Board.
5.
The designated representatives of the Member States shall adopt the Board’s rules of procedure by a two-thirds
majority.
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This
Regulation includes collecting relevant
data and information to help the
Board fulfill its tasks.
5. The representatives from the
Member States will approve the
Board’s rules of procedure with a two-thirds majority. These rules will outline how to select the Chair, the length of their term, their responsibilities, voting procedures, and how the
Board and its sub-groups will operate.
6. The
Board will create two permanent sub-groups to promote cooperation and information sharing among
market surveillance authorities and
notifying authorities regarding market surveillance and
notified bodies. The market surveillance sub-group will serve as the administrative cooperation group (ADCO) as defined in
Article 30 of Regulation (EU) 2019/1020. The
Board may also form additional sub-groups, either permanent or temporary, to address specific issues. When appropriate, representatives from the
advisory forum mentioned in
Article 67 may be invited to participate as observers in these sub-groups or specific meetings.
7. The
Board will be structured and function in a way that ensures its activities are objective and impartial.
8. The
Board will be led by a representative from the
Member States. The
AI Office will provide secretarial support for the
Board, organize meetings at the Chair's request, and prepare the agenda based on the
Board's tasks as outlined in this
Regulation and its rules of procedure.
Article 66: The
Board's Tasks
The
Board will advise and assist the
Commission and
Member States to ensure the consistent and effective application of this
Regulation.
of this Regulation, including through the collection of relevant data and information for
the purpose of fulfilling their tasks on the Board.
5.
The designated representatives of the Member States shall adopt the Board’s rules of procedure by a two-thirds
majority. The rules of procedure shall, in particular, lay down procedures for the selection process, the duration of the
mandate of, and specifications of the tasks of, the Chair, detailed arrangements for voting, and the organisation of the
Board’s activities and those of its sub-groups.
6.
The Board shall establish two standing sub-groups to provide a platform for cooperation and exchange among market
surveillance authorities and notifying authorities about issues related to market surveillance and notified bodies respectively.
The standing sub-group for market surveillance should act as the administrative cooperation group (ADCO) for this
Regulation within the meaning of Article 30 of Regulation (EU) 2019/1020.
The Board may establish other standing or temporary sub-groups as appropriate for the purpose of examining specific
issues. Where appropriate, representatives of the advisory forum referred to in Article 67 may be invited to such sub-groups
or to specific meetings of those subgroups as observers.
7.
The Board shall be organised and operated so as to safeguard the objectivity and impartiality of its activities.
8.
The Board shall be chaired by one of the representatives of the Member States. The AI Office shall provide the
secretariat for the Board, convene the meetings upon request of the Chair, and prepare the agenda in accordance with the
tasks of the Board pursuant to this Regulation and its rules of procedure.
Article 66
Tasks of the Board
The Board shall advise and assist the Commission and the Member States in order to facilitate the consistent and effective
application of this Regulation.
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Article 66 outlines the tasks of the
Board under this
Regulation. The
Board's main role is to support the
Commission and
Member States in applying this
Regulation consistently and effectively. Specifically, the
Board can: (a) help coordinate
national authorities responsible for enforcing this
Regulation and, with the agreement of
market surveillance authorities, support their joint activities; (b) gather and share technical and regulatory knowledge and best practices among
Member States; (c) advise on how to implement this
Regulation, especially regarding rules for
general-purpose AI models; (d) help standardize administrative practices across
Member States, including exceptions to
conformity assessment procedures, the operation of
AI regulatory sandboxes, and real-world testing; (e) issue recommendations and written opinions on relevant matters related to the
Regulation's implementation, either at the
Commission's request or on its own initiative. This includes advice on developing
codes of conduct, evaluating the
Regulation, and providing insights on technical specifications or existing standards.
tasks of the Board pursuant to this Regulation and its rules of procedure.
Article 66
Tasks of the Board
The Board shall advise and assist the Commission and the Member States in order to facilitate the consistent and effective
application of this Regulation. To that end, the Board may in particular:
(a)
contribute to the coordination among national competent authorities responsible for the application of this Regulation
and, in cooperation with and subject to the agreement of the market surveillance authorities concerned, support joint
activities of market surveillance authorities referred to in Article 74(11);
(b) collect and share technical and regulatory expertise and best practices among Member States;
(c)
provide advice on the implementation of this Regulation, in particular as regards the enforcement of rules on
general-purpose AI models;
(d) contribute to the harmonisation of administrative practices in the Member States, including in relation to the
derogation from the conformity assessment procedures referred to in Article 46, the functioning of AI regulatory
sandboxes, and testing in real world conditions referred to in Articles 57, 59 and 60;
(e)
at the request of the Commission or on its own initiative, issue recommendations and written opinions on any relevant
matters related to the implementation of this Regulation and to its consistent and effective application, including:
(i) on the development and application of codes of conduct and codes of practice pursuant to this Regulation, as well
as of the Commission’s guidelines;
(ii) the evaluation and review of this Regulation pursuant to Article 112, including as regards the serious incident
reports referred to in Article 73, and the functioning of the EU database referred to in Article 71, the preparation
of the delegated or implementing acts, and as regards possible alignments of this Regulation with the Union
harmonisation legislation listed in Annex I;
(iii) on technical specifications or existing standards regarding the requirements set out in Chapter III, Section 2;
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This
Regulation aligns with the EU harmonization laws listed in
Annex I. It covers: (iii) technical specifications or existing standards related to
Chapter III, Section 2; (iv) the use of harmonized standards or
common specifications mentioned in
Articles 40 and 41; (v) trends in European competitiveness in
AI,
AI adoption in the EU, and the development of digital skills; (vi) trends in
AI value chains and their implications for accountability; (vii) the potential need to amend
Annex III as per
Article 7 and possibly revise
Article 5 according to
Article 112, based on available evidence and technological advancements. Additionally, it aims to: (f) support the
Commission in promoting
AI literacy and public understanding of the benefits, risks,
safeguards, and rights related to
AI systems; (g) help develop common criteria and a shared understanding among market operators and authorities regarding the concepts in this
Regulation, including
benchmarks; (h) cooperate with other EU institutions, bodies, and relevant expert groups in areas like product safety,
cybersecurity, competition, digital services, financial services, consumer protection, and
data rights; (i) contribute to effective collaboration with authorities in other countries and international organizations; (j) assist
national authorities and the
Commission in building the necessary organizational and technical expertise for implementing this
Regulation.
alignments of this Regulation with the Union
harmonisation legislation listed in Annex I;
(iii) on technical specifications or existing standards regarding the requirements set out in Chapter III, Section 2;
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(iv) on the use of harmonised standards or common specifications referred to in Articles 40 and 41;
(v) trends, such as European global competitiveness in AI, the uptake of AI in the Union, and the development of
digital skills;
(vi) trends on the evolving typology of AI value chains, in particular on the resulting implications in terms of
accountability;
(vii) on the potential need for amendment to Annex III in accordance with Article 7, and on the potential need for
possible revision of Article 5 pursuant to Article 112, taking into account relevant available evidence and the
latest developments in technology;
(f)
support the Commission in promoting AI literacy, public awareness and understanding of the benefits, risks,
safeguards and rights and obligations in relation to the use of AI systems;
(g) facilitate the development of common criteria and a shared understanding among market operators and competent
authorities of the relevant concepts provided for in this Regulation, including by contributing to the development of
benchmarks;
(h) cooperate, as appropriate, with other Union institutions, bodies, offices and agencies, as well as relevant Union expert
groups and networks, in particular in the fields of product safety, cybersecurity, competition, digital and media services,
financial services, consumer protection, data and fundamental rights protection;
(i)
contribute to effective cooperation with the competent authorities of third countries and with international
organisations;
(j)
assist national competent authorities and the Commission in developing the organisational and technical expertise
required for the implementation of this Regulation, including by contributing to the assessment of
Show original text
To ensure effective collaboration with authorities in other countries and international organizations, the following actions will be taken: (j) Support
national authorities and the
Commission in building the necessary organizational and technical skills for implementing this
Regulation, including assessing training needs for staff in
Member States. (k) Help the
AI Office assist
national authorities in creating and developing
AI regulatory sandboxes, and promote cooperation and information sharing among these sandboxes. (l) Contribute to and provide advice on creating guidance documents. (m) Advise the
Commission on international
AI matters. (n) Offer opinions to the
Commission regarding qualified alerts about
general-purpose AI models. (o) Gather opinions from
Member States on qualified alerts concerning
general-purpose AI models and share national experiences and practices related to monitoring and enforcing
AI systems, especially those using
general-purpose AI models.
Article 67 establishes an
advisory forum to provide technical expertise and advice to the
Board and the
Commission, aiding their responsibilities under this
Regulation. The forum will include a balanced mix of
stakeholders from industry,
start-ups,
SMEs, civil society, and academia, ensuring representation of both commercial and non-commercial interests, as well as a focus on
SMEs. The
Commission will appoint members based on these criteria from recognized experts in the
AI field.
to effective cooperation with the competent authorities of third countries and with international
organisations;
(j)
assist national competent authorities and the Commission in developing the organisational and technical expertise
required for the implementation of this Regulation, including by contributing to the assessment of training needs for
staff of Member States involved in implementing this Regulation;
(k) assist the AI Office in supporting national competent authorities in the establishment and development of AI
regulatory sandboxes, and facilitate cooperation and information-sharing among AI regulatory sandboxes;
(l)
contribute to, and provide relevant advice on, the development of guidance documents;
(m) advise the Commission in relation to international matters on AI;
(n) provide opinions to the Commission on the qualified alerts regarding general-purpose AI models;
(o) receive opinions by the Member States on qualified alerts regarding general-purpose AI models, and on national
experiences and practices on the monitoring and enforcement of AI systems, in particular systems integrating the
general-purpose AI models.
Article 67
Advisory forum
1.
An advisory forum shall be established to provide technical expertise and advise the Board and the Commission, and
to contribute to their tasks under this Regulation.
2.
The membership of the advisory forum shall represent a balanced selection of stakeholders, including industry,
start-ups, SMEs, civil society and academia. The membership of the advisory forum shall be balanced with regard to
commercial and non-commercial interests and, within the category of commercial interests, with regard to SMEs and other
undertakings.
3.
The Commission shall appoint the members of the advisory forum, in accordance with the criteria set out in
paragraph 2, from amongst stakeholders with recognised expertise in the field of AI.
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4.
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The
advisory forum will have members serving a two-year term, which can be extended for up to four additional years. Permanent members of the forum include the
Fundamental Rights Agency,
ENISA, the European Committee for Standardization (
CEN), the European Committee for Electrotechnical Standardization (
CENELEC), and the European Telecommunications Standards Institute (
ETSI). The forum will create its own rules and elect two co-chairs from its members, who will serve for two years and can be re-elected once. The forum will meet at least twice a year and can invite experts and
stakeholders to participate. It can also prepare opinions, recommendations, and written contributions when requested by the
Board or the
Commission. Additionally, the forum may form permanent or temporary sub-groups to address specific issues related to its objectives. An annual report on the forum's activities will be prepared and made publicly available. The
Commission will establish a
scientific panel of independent experts to assist with enforcement activities under this
Regulation through an implementing act, which will follow the examination procedure outlined in
Article 98(2).
with recognised expertise in the field of AI.
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4.
The term of office of the members of the advisory forum shall be two years, which may be extended by up to no more
than four years.
5.
The Fundamental Rights Agency, ENISA, the European Committee for Standardization (CEN), the European
Committee for Electrotechnical Standardization (CENELEC), and the European Telecommunications Standards Institute
(ETSI) shall be permanent members of the advisory forum.
6.
The advisory forum shall draw up its rules of procedure. It shall elect two co-chairs from among its members, in
accordance with criteria set out in paragraph 2. The term of office of the co-chairs shall be two years, renewable once.
7.
The advisory forum shall hold meetings at least twice a year. The advisory forum may invite experts and other
stakeholders to its meetings.
8.
The advisory forum may prepare opinions, recommendations and written contributions at the request of the Board or
the Commission.
9.
The advisory forum may establish standing or temporary sub-groups as appropriate for the purpose of examining
specific questions related to the objectives of this Regulation.
10.
The advisory forum shall prepare an annual report on its activities. That report shall be made publicly available.
Article 68
Scientific panel of independent experts
1.
The Commission shall, by means of an implementing act, make provisions on the establishment of a scientific panel
of independent experts (the ‘scientific panel’) intended to support the enforcement activities under this Regulation. That
implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).
2.
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A
scientific panel of independent experts, referred to as the '
scientific panel', will be established to assist with enforcing this
Regulation. This panel will be created through an implementing act that follows the examination procedure outlined in
Article 98(2).
The panel will be made up of experts chosen by the
Commission based on their current scientific or technical knowledge in the field of
AI. These experts must meet the following criteria:
(a) possess specific expertise and competence in
AI;
(b) be independent from any
AI system providers or
general-purpose AI models;
(c) be capable of performing their duties diligently, accurately, and objectively.
The
Commission, in consultation with the
Board, will decide how many experts are needed on the panel, ensuring fair representation in terms of gender and geography.
The
scientific panel will advise and support the
AI Office, particularly in the following areas:
(a) helping to implement and enforce this
Regulation concerning
general-purpose AI models and systems by:
(i) notifying the
AI Office about potential
systemic risks of
general-purpose AI models at the
Union level, as per
Article 90;
(ii) assisting in developing tools and methods to evaluate the capabilities of
general-purpose AI models and systems, including
benchmarks;
(iii) advising on how to classify
general-purpose AI models that pose
systemic risks;
(iv) providing guidance on classifying various
general-purpose AI models and systems.
establishment of a scientific panel
of independent experts (the ‘scientific panel’) intended to support the enforcement activities under this Regulation. That
implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).
2.
The scientific panel shall consist of experts selected by the Commission on the basis of up-to-date scientific or
technical expertise in the field of AI necessary for the tasks set out in paragraph 3, and shall be able to demonstrate meeting
all of the following conditions:
(a) having particular expertise and competence and scientific or technical expertise in the field of AI;
(b) independence from any provider of AI systems or general-purpose AI models;
(c) an ability to carry out activities diligently, accurately and objectively.
The Commission, in consultation with the Board, shall determine the number of experts on the panel in accordance with
the required needs and shall ensure fair gender and geographical representation.
3.
The scientific panel shall advise and support the AI Office, in particular with regard to the following tasks:
(a) supporting the implementation and enforcement of this Regulation as regards general-purpose AI models and systems,
in particular by:
(i) alerting the AI Office of possible systemic risks at Union level of general-purpose AI models, in accordance with
Article 90;
(ii) contributing to the development of tools and methodologies for evaluating capabilities of general-purpose AI
models and systems, including through benchmarks;
(iii) providing advice on the classification of general-purpose AI models with systemic risk;
(iv) providing advice on the classification of various general-purpose AI models and systems;
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systems, including through benchmarks;
(iii) providing advice on the classification of general-purpose AI models with systemic risk;
(iv) providing advice on the classification of various general-purpose AI models and systems;
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(v) contributing to the development of tools and templates;
(b) supporting the work of market surveillance authorities, at their request;
(c) supporting cross-border market surveillance activities as referred to in Article 74(11), without prejudice to the powers
of market surveillance authorities;
(d) supporting the AI Office in carrying out its duties in the context of the Union safeguard procedure pursuant to
Article 81.
4.
The experts on the scientific panel shall perform their tasks with impartiality and objectivity, and shall ensure the
confidentiality of information and data obtained in carrying out their tasks and activities. They shall neither seek nor take
instructions from anyone when exercising their tasks under paragraph 3. Each expert shall draw up a declaration of
interests, which shall be made publicly available. The AI Office shall establish systems and procedures to actively manage
and prevent potential conflicts of interest.
5.
The implementing act referred to in paragraph 1 shall include provisions on the conditions, procedures and detailed
arrangements for the scientific panel and its members to issue alerts, and to request the assistance of the AI Office for the
performance of the tasks of the scientific panel.
Article 69
Access to the pool of experts by the Member States
1.
Member States may call upon experts of the scientific panel to support their enforcement activities under this
Regulation.
2.
The Member States may be required to pay fees for the advice and support provided by the experts.
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Member States can request help from experts in the
scientific panel to assist with enforcing this
Regulation. They may need to pay fees for this expert advice, and the details about these fees and costs will be outlined in an implementing act mentioned in
Article 68(1). This will consider the goals of effectively implementing the
Regulation, being cost-effective, and ensuring all
Member States can access experts. The
Commission will help
Member States access these experts promptly and will coordinate support activities from
Union AI testing and experts to maximize their effectiveness.
Each
Member State must establish or designate at least one
notifying authority and one
market surveillance authority as
national competent authorities for this
Regulation. These authorities must operate independently and fairly to maintain objectivity in their work and ensure the
Regulation is applied correctly. Members of these authorities should avoid any actions that conflict with their responsibilities. If these principles are followed, one or more designated authorities can carry out these tasks based on the
Member State's needs.
Member States must inform the
Commission about the identities and tasks of their notifying and
market surveillance authorities and any changes to this information. They should also provide public access to contact information for these authorities through electronic means by August 2, 2025.
experts by the Member States
1.
Member States may call upon experts of the scientific panel to support their enforcement activities under this
Regulation.
2.
The Member States may be required to pay fees for the advice and support provided by the experts. The structure and
the level of fees as well as the scale and structure of recoverable costs shall be set out in the implementing act referred to in
Article 68(1), taking into account the objectives of the adequate implementation of this Regulation, cost-effectiveness and
the necessity of ensuring effective access to experts for all Member States.
3.
The Commission shall facilitate timely access to the experts by the Member States, as needed, and ensure that the
combination of support activities carried out by Union AI testing support pursuant to Article 84 and experts pursuant to
this Article is efficiently organised and provides the best possible added value.
SECTION 2
National competent authorities
Article 70
Designation of national competent authorities and single points of contact
1.
Each Member State shall establish or designate as national competent authorities at least one notifying authority and
at least one market surveillance authority for the purposes of this Regulation. Those national competent authorities shall
exercise their powers independently, impartially and without bias so as to safeguard the objectivity of their activities and
tasks, and to ensure the application and implementation of this Regulation. The members of those authorities shall refrain
from any action incompatible with their duties. Provided that those principles are observed, such activities and tasks may be
performed by one or more designated authorities, in accordance with the organisational needs of the Member State.
2.
Member States shall communicate to the Commission the identity of the notifying authorities and the market
surveillance authorities and the tasks of those authorities, as well as any subsequent changes thereto. Member States shall
make publicly available information on how competent authorities and single points of contact can be contacted, through
electronic communication means by 2 August 2025.
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Member States must publicly share information on how to contact their
competent authorities and single points of contact by August 2, 2025. They are required to designate a
market surveillance authority as the single point of contact for this
Regulation and inform the
Commission of its identity. The
Commission will then publish a list of these contacts.
Member States must ensure that their
national competent authorities have enough technical, financial, and human resources, as well as the necessary infrastructure to effectively carry out their responsibilities under this
Regulation. These authorities should have a sufficient number of staff with expertise in
AI technologies,
data protection,
cybersecurity,
fundamental rights,
health and safety risks, and knowledge of relevant standards and legal requirements.
Member States should review and update these resource and competence needs annually.
National competent authorities must implement measures to maintain a high level of
cybersecurity and must adhere to confidentiality
obligations as outlined in
Article 78.
By August 2, 2025, and every two years thereafter,
Member States are required to report to the
Commission on the status of their
national competent authorities' financial and human resources, including an evaluation of their adequacy. The
Commission will share this information with the
Board for discussion and potential recommendations.
The
Commission will also support the sharing of experiences among
national competent authorities.
the tasks of those authorities, as well as any subsequent changes thereto. Member States shall
make publicly available information on how competent authorities and single points of contact can be contacted, through
electronic communication means by 2 August 2025. Member States shall designate a market surveillance authority to act as
the single point of contact for this Regulation, and shall notify the Commission of the identity of the single point of contact.
The Commission shall make a list of the single points of contact publicly available.
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3.
Member States shall ensure that their national competent authorities are provided with adequate technical, financial
and human resources, and with infrastructure to fulfil their tasks effectively under this Regulation. In particular, the national
competent authorities shall have a sufficient number of personnel permanently available whose competences and expertise
shall include an in-depth understanding of AI technologies, data and data computing, personal data protection,
cybersecurity, fundamental rights, health and safety risks and knowledge of existing standards and legal requirements.
Member States shall assess and, if necessary, update competence and resource requirements referred to in this paragraph on
an annual basis.
4.
National competent authorities shall take appropriate measures to ensure an adequate level of cybersecurity.
5.
When performing their tasks, the national competent authorities shall act in accordance with the confidentiality
obligations set out in Article 78.
6.
By 2 August 2025, and once every two years thereafter, Member States shall report to the Commission on the status
of the financial and human resources of the national competent authorities, with an assessment of their adequacy. The
Commission shall transmit that information to the Board for discussion and possible recommendations.
7.
The Commission shall facilitate the exchange of experience between national competent authorities.
8.
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The
Commission will evaluate the resources and personnel of
national authorities and share this information with the
Board for discussion and potential recommendations. Additionally, the
Commission will help
national authorities share their experiences with each other.
National authorities can offer guidance on implementing this
Regulation, especially for small and medium-sized enterprises (
SMEs) and
start-ups, while considering advice from the
Board and the
Commission. If
national authorities plan to give guidance on
AI systems related to other EU laws, they must consult the relevant authorities for those laws. For EU institutions, bodies, offices, or agencies covered by this
Regulation, the
European Data Protection Supervisor will oversee their compliance.
CHAPTER VIII
EU DATABASE FOR HIGH-RISK AI SYSTEMS
Article 71
EU Database for High-Risk AI Systems Listed in
Annex III
1. The
Commission, in partnership with
Member States, will create and maintain an
EU database that includes information about
high-risk AI systems as defined in
Article 6(2), which are registered according to Articles 49 and 60, as well as
AI systems not classified as high-risk under
Article 6(3) that are registered according to
Article 6(4) and
Article 49. The
Commission will consult relevant experts when establishing and updating the database's specifications.
2.
Providers or their authorized representatives must enter the
data specified in Sections A and B of
Annex VIII into the
EU database.
and human resources of the national competent authorities, with an assessment of their adequacy. The
Commission shall transmit that information to the Board for discussion and possible recommendations.
7.
The Commission shall facilitate the exchange of experience between national competent authorities.
8.
National competent authorities may provide guidance and advice on the implementation of this Regulation, in
particular to SMEs including start-ups, taking into account the guidance and advice of the Board and the Commission, as
appropriate. Whenever national competent authorities intend to provide guidance and advice with regard to an AI system
in areas covered by other Union law, the national competent authorities under that Union law shall be consulted, as
appropriate.
9.
Where Union institutions, bodies, offices or agencies fall within the scope of this Regulation, the European Data
Protection Supervisor shall act as the competent authority for their supervision.
CHAPTER VIII
EU DATABASE FOR HIGH-RISK AI SYSTEMS
Article 71
EU database for high-risk AI systems listed in Annex III
1.
The Commission shall, in collaboration with the Member States, set up and maintain an EU database containing
information referred to in paragraphs 2 and 3 of this Article concerning high-risk AI systems referred to in Article 6(2)
which are registered in accordance with Articles 49 and 60 and AI systems that are not considered as high-risk pursuant to
Article 6(3) and which are registered in accordance with Article 6(4) and Article 49. When setting the functional
specifications of such database, the Commission shall consult the relevant experts, and when updating the functional
specifications of such database, the Commission shall consult the Board.
2.
The data listed in Sections A and B of Annex VIII shall be entered into the EU database by the provider or, where
applicable, by the authorised representative.
3.
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1. The
Commission will consult the
Board regarding the specifications of the database. 2. The
data in Sections A and B of
Annex VIII must be entered into the
EU database by the
provider or their authorized representative. 3. The
data in Section C of
Annex VIII must be entered by the
deployer, who represents a public authority, agency, or body, as per
Article 49(3) and (4). 4. Most information in the
EU database, as registered under
Article 49, will be publicly accessible and easy to navigate, except for the information mentioned in
Article 49(4) and
Article 60(4)(c).
Data registered under
Article 60 will only be available to
market surveillance authorities and the
Commission, unless the
provider consents to public access. 5. The
EU database will only contain
personal data that is necessary for information collection and processing, including names and contact details of individuals responsible for system registration and authorized to represent the
provider or
deployer. 6. The
Commission will manage the
EU database and provide technical and administrative support to
providers and deployers, ensuring the database meets accessibility standards.
specifications of such database, the Commission shall consult the Board.
2.
The data listed in Sections A and B of Annex VIII shall be entered into the EU database by the provider or, where
applicable, by the authorised representative.
3.
The data listed in Section C of Annex VIII shall be entered into the EU database by the deployer who is, or who acts on
behalf of, a public authority, agency or body, in accordance with Article 49(3) and (4).
4.
With the exception of the section referred to in Article 49(4) and Article 60(4), point (c), the information contained in
the EU database registered in accordance with Article 49 shall be accessible and publicly available in a user-friendly manner.
The information should be easily navigable and machine-readable. The information registered in accordance with Article 60
shall be accessible only to market surveillance authorities and the Commission, unless the prospective provider or provider
has given consent for also making the information accessible the public.
5.
The EU database shall contain personal data only in so far as necessary for collecting and processing information in
accordance with this Regulation. That information shall include the names and contact details of natural persons who are
responsible for registering the system and have the legal authority to represent the provider or the deployer, as applicable.
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6.
The Commission shall be the controller of the EU database. It shall make available to providers, prospective providers
and deployers adequate technical and administrative support. The EU database shall comply with the applicable accessibility
requirements.
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The
Commission will manage the
EU database and provide technical and administrative support to
providers, potential
providers, and deployers. The database must meet accessibility standards.
**CHAPTER IX: POST-MARKET MONITORING, INFORMATION SHARING, AND MARKET SURVEILLANCE**
**SECTION 1: Post-Market Monitoring**
**
Article 72: Post-Market Monitoring by
Providers and Plan for
High-Risk AI Systems**
1.
Providers must create and document a
post-market monitoring system that matches the nature and risks of high-risk
AI technologies.
2. This system should actively collect, document, and analyze relevant
data on the performance of
high-risk AI systems throughout their lifecycle. This
data can come from deployers or other sources and will help
providers ensure ongoing compliance with the requirements in
Chapter III, Section 2. If applicable, the monitoring should also assess how these
AI systems interact with others. However, it will not include
sensitive operational data from
law enforcement agencies.
3. The
post-market monitoring system must follow a
post-market monitoring plan, which is part of the
technical documentation outlined in
Annex IV. The
Commission will create a detailed template for this plan and specify what it should include by February 2, 2026, following the examination procedure in
Article 98(2).
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6.
The Commission shall be the controller of the EU database. It shall make available to providers, prospective providers
and deployers adequate technical and administrative support. The EU database shall comply with the applicable accessibility
requirements.
CHAPTER IX
POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE
SECTION 1
Post-market monitoring
Article 72
Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems
1.
Providers shall establish and document a post-market monitoring system in a manner that is proportionate to the
nature of the AI technologies and the risks of the high-risk AI system.
2.
The post-market monitoring system shall actively and systematically collect, document and analyse relevant data
which may be provided by deployers or which may be collected through other sources on the performance of high-risk AI
systems throughout their lifetime, and which allow the provider to evaluate the continuous compliance of AI systems with
the requirements set out in Chapter III, Section 2. Where relevant, post-market monitoring shall include an analysis of the
interaction with other AI systems. This obligation shall not cover sensitive operational data of deployers which are
law-enforcement authorities.
3.
The post-market monitoring system shall be based on a post-market monitoring plan. The post-market monitoring
plan shall be part of the technical documentation referred to in Annex IV. The Commission shall adopt an implementing act
laying down detailed provisions establishing a template for the post-market monitoring plan and the list of elements to be
included in the plan by 2 February 2026. That implementing act shall be adopted in accordance with the examination
procedure referred to in Article 98(2).
4.
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By February 2, 2026, a plan for post-market monitoring and a list of required elements must be established. This plan will be adopted following the examination procedure outlined in
Article 98(2). For
high-risk AI systems that are already covered by existing
Union harmonization legislation (as listed in
Section A of Annex I),
providers can integrate the necessary elements from the new plan into their existing systems, as long as they maintain the same level of protection. This also applies to
high-risk AI systems mentioned in point 5 of
Annex III that are used by financial institutions, which must comply with
Union financial services laws regarding their internal governance and processes.
Section 2: Sharing Information on Serious Incidents
Article 73: Reporting Serious Incidents
1.
Providers of
high-risk AI systems sold in the
Union must report any serious incidents to the
market surveillance authorities in the
Member States where the incidents occurred.
2. Reports must be made immediately after the
provider identifies a causal link between the
AI system and the
serious incident, or if there is a reasonable likelihood of such a link. Reports must be submitted no later than
15 days after the
provider or
deployer becomes aware of the incident, taking into account the severity of the incident.
3.
for the post-market monitoring plan and the list of elements to be
included in the plan by 2 February 2026. That implementing act shall be adopted in accordance with the examination
procedure referred to in Article 98(2).
4.
For high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I, where
a post-market monitoring system and plan are already established under that legislation, in order to ensure consistency,
avoid duplications and minimise additional burdens, providers shall have a choice of integrating, as appropriate, the
necessary elements described in paragraphs 1, 2 and 3 using the template referred in paragraph 3 into systems and plans
already existing under that legislation, provided that it achieves an equivalent level of protection.
The first subparagraph of this paragraph shall also apply to high-risk AI systems referred to in point 5 of Annex III placed
on the market or put into service by financial institutions that are subject to requirements under Union financial services
law regarding their internal governance, arrangements or processes.
SECTION 2
Sharing of information on serious incidents
Article 73
Reporting of serious incidents
1.
Providers of high-risk AI systems placed on the Union market shall report any serious incident to the market
surveillance authorities of the Member States where that incident occurred.
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2.
The report referred to in paragraph 1 shall be made immediately after the provider has established a causal link
between the AI system and the serious incident or the reasonable likelihood of such a link, and, in any event, not later than
15 days after the provider or, where applicable, the deployer, becomes aware of the serious incident.
The period for the reporting referred to in the first subparagraph shall take account of the severity of the serious incident.
3.
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Providers or deployers must report serious incidents within
15 days of becoming aware of them, considering the incident's severity. However, if there is a
widespread infringement or a
serious incident as defined in
Article 3, point (49)(b), the report must be made immediately and no later than 2 days after awareness. In cases of a person's death, the report should be made immediately upon establishing or suspecting a link between the
high-risk AI system and the incident, but no later than 10 days after awareness.
Providers or deployers can submit an initial incomplete report if necessary, followed by a complete one. After reporting a
serious incident, the
provider must promptly investigate the incident and the
AI system involved, including conducting a
risk assessment and taking corrective actions. They must cooperate with relevant authorities during these investigations and cannot alter the
AI system in a way that could affect the evaluation of the incident's causes without informing the authorities first.
, not later than
15 days after the provider or, where applicable, the deployer, becomes aware of the serious incident.
The period for the reporting referred to in the first subparagraph shall take account of the severity of the serious incident.
3.
Notwithstanding paragraph 2 of this Article, in the event of a widespread infringement or a serious incident as
defined in Article 3, point (49)(b), the report referred to in paragraph 1 of this Article shall be provided immediately, and
not later than two days after the provider or, where applicable, the deployer becomes aware of that incident.
4.
Notwithstanding paragraph 2, in the event of the death of a person, the report shall be provided immediately after the
provider or the deployer has established, or as soon as it suspects, a causal relationship between the high-risk AI system and
the serious incident, but not later than 10 days after the date on which the provider or, where applicable, the deployer
becomes aware of the serious incident.
5.
Where necessary to ensure timely reporting, the provider or, where applicable, the deployer, may submit an initial
report that is incomplete, followed by a complete report.
6.
Following the reporting of a serious incident pursuant to paragraph 1, the provider shall, without delay, perform the
necessary investigations in relation to the serious incident and the AI system concerned. This shall include a risk assessment
of the incident, and corrective action.
The provider shall cooperate with the competent authorities, and where relevant with the notified body concerned, during
the investigations referred to in the first subparagraph, and shall not perform any investigation which involves altering the
AI system concerned in a way which may affect any subsequent evaluation of the causes of the incident, prior to informing
the competent authorities of such action.
7.
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Before making any changes to an
AI system that could affect future investigations, the responsible party must inform the relevant authorities.
When a
serious incident occurs, as defined in
Article 3, point (49)(c), the
market surveillance authority must notify the
national public authorities mentioned in
Article 77(1). The
Commission will create specific guidance to help ensure compliance with these requirements, which will be available by August 2, 2025, and will be reviewed regularly.
The
market surveillance authority is required to take necessary actions within seven days of receiving the incident notification, following the procedures outlined in
Regulation (EU) 2019/1020.
For
high-risk AI systems listed in
Annex III that are marketed by
providers under EU laws with similar reporting requirements, notifications of serious incidents will only include those specified in
Article 3, point (49)(c).
For
high-risk AI systems that are
safety components of devices or are devices themselves, as covered by Regulations (EU) 2017/745 and (EU)
2017/746, notifications of serious incidents will also be limited to those in
Article 3, point (49)(c) and must be sent to the national authority designated by the
Member States where the incident took place.
referred to in the first subparagraph, and shall not perform any investigation which involves altering the
AI system concerned in a way which may affect any subsequent evaluation of the causes of the incident, prior to informing
the competent authorities of such action.
7.
Upon receiving a notification related to a serious incident referred to in Article 3, point (49)(c), the relevant market
surveillance authority shall inform the national public authorities or bodies referred to in Article 77(1). The Commission
shall develop dedicated guidance to facilitate compliance with the obligations set out in paragraph 1 of this Article. That
guidance shall be issued by 2 August 2025, and shall be assessed regularly.
8.
The market surveillance authority shall take appropriate measures, as provided for in Article 19 of Regulation (EU)
2019/1020, within seven days from the date it received the notification referred to in paragraph 1 of this Article, and shall
follow the notification procedures as provided in that Regulation.
9.
For high-risk AI systems referred to in Annex III that are placed on the market or put into service by providers that are
subject to Union legislative instruments laying down reporting obligations equivalent to those set out in this Regulation, the
notification of serious incidents shall be limited to those referred to in Article 3, point (49)(c).
10.
For high-risk AI systems which are safety components of devices, or are themselves devices, covered by Regulations
(EU) 2017/745 and (EU) 2017/746, the notification of serious incidents shall be limited to those referred to in Article 3,
point (49)(c) of this Regulation, and shall be made to the national competent authority chosen for that purpose by the
Member States where the incident occurred.
11.
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serious incidents shall be limited to those referred to in Article 3,
point (49)(c) of this Regulation, and shall be made to the national competent authority chosen for that purpose by the
Member States where the incident occurred.
11.
National competent authorities shall immediately notify the Commission of any serious incident, whether or not
they have taken action on it, in accordance with Article 20 of Regulation (EU) 2019/1020.
SECTION 3
Enforcement
Article 74
Market surveillance and control of AI systems in the Union market
1.
Regulation (EU) 2019/1020 shall apply to AI systems covered by this Regulation. For the purposes of the effective
enforcement of this Regulation:
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(a) any reference to an economic operator under Regulation (EU) 2019/1020 shall be understood as including all operators
identified in Article 2(1) of this Regulation;
(b) any reference to a product under Regulation (EU) 2019/1020 shall be understood as including all AI systems falling
within the scope of this Regulation.
2.
As part of their reporting obligations under Article 34(4) of Regulation (EU) 2019/1020, the market surveillance
authorities shall report annually to the Commission and relevant national competition authorities any information
identified in the course of market surveillance activities that may be of potential interest for the application of Union law on
competition rules. They shall also annually report to the Commission about the use of prohibited practices that occurred
during that year and about the measures taken.
3.
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course of market surveillance activities that may be of potential interest for the application of Union law on
competition rules. They shall also annually report to the Commission about the use of prohibited practices that occurred
during that year and about the measures taken.
3.
For high-risk AI systems related to products covered by the Union harmonisation legislation listed in Section A of
Annex I, the market surveillance authority for the purposes of this Regulation shall be the authority responsible for market
surveillance activities designated under those legal acts.
By derogation from the first subparagraph, and in appropriate circumstances, Member States may designate another
relevant authority to act as a market surveillance authority, provided they ensure coordination with the relevant sectoral
market surveillance authorities responsible for the enforcement of the Union harmonisation legislation listed in Annex I.
4.
The procedures referred to in Articles 79 to 83 of this Regulation shall not apply to AI systems related to products
covered by the Union harmonisation legislation listed in section A of Annex I, where such legal acts already provide for
procedures ensuring an equivalent level of protection and having the same objective. In such cases, the relevant sectoral
procedures shall apply instead.
5.
Without prejudice to the powers of market surveillance authorities under Article 14 of Regulation (EU) 2019/1020,
for the purpose of ensuring the effective enforcement of this Regulation, market surveillance authorities may exercise the
powers referred to in Article 14(4), points (d) and (j), of that Regulation remotely, as appropriate.
6.
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To ensure effective enforcement of this
Regulation,
market surveillance authorities can use the powers mentioned in
Article 14(4), points (d) and (j), remotely when appropriate. For
high-risk AI systems used by financial institutions regulated by EU financial services law, the relevant national authority responsible for supervising these institutions will act as the
market surveillance authority, as long as the
AI system's use is directly related to providing financial services. However, in certain situations and with proper coordination, a different authority may be designated by the
Member State as the
market surveillance authority. National
market surveillance authorities overseeing regulated credit institutions under
Directive 2013/36/EU, which are part of the Single Supervisory Mechanism established by
Regulation (EU) No 1024/2013, must promptly report any relevant information from their market surveillance activities to the
European Central Bank, as it may be important for the Bank's supervisory tasks. For
high-risk AI systems used in
law enforcement, border management, and justice, as well as those listed in points 6, 7, and 8 of
Annex III,
Member States must designate either the competent
data protection supervisory authorities under
Regulation (EU) 2016/679 or
Directive (EU) 2016/680, or another designated authority as the
market surveillance authority.
0,
for the purpose of ensuring the effective enforcement of this Regulation, market surveillance authorities may exercise the
powers referred to in Article 14(4), points (d) and (j), of that Regulation remotely, as appropriate.
6.
For high-risk AI systems placed on the market, put into service, or used by financial institutions regulated by Union
financial services law, the market surveillance authority for the purposes of this Regulation shall be the relevant national
authority responsible for the financial supervision of those institutions under that legislation in so far as the placing on the
market, putting into service, or the use of the AI system is in direct connection with the provision of those financial
services.
7.
By way of derogation from paragraph 6, in appropriate circumstances, and provided that coordination is ensured,
another relevant authority may be identified by the Member State as market surveillance authority for the purposes of this
Regulation.
National market surveillance authorities supervising regulated credit institutions regulated under Directive 2013/36/EU,
which are participating in the Single Supervisory Mechanism established by Regulation (EU) No 1024/2013, should report,
without delay, to the European Central Bank any information identified in the course of their market surveillance activities
that may be of potential interest for the prudential supervisory tasks of the European Central Bank specified in that
Regulation.
8.
For high-risk AI systems listed in point 1 of Annex III to this Regulation, in so far as the systems are used for law
enforcement purposes, border management and justice and democracy, and for high-risk AI systems listed in points 6, 7
and 8 of Annex III to this Regulation, Member States shall designate as market surveillance authorities for the purposes of
this Regulation either the competent data protection supervisory authorities under Regulation (EU) 2016/679 or Directive
(EU) 2016/680, or any other authority designated pursuant to
Show original text
Market surveillance authorities for this
Regulation will be either the
data protection supervisory authorities under
Regulation (EU) 2016/679 or
Directive (EU) 2016/680, or any other authority designated according to Articles 41 to 44 of
Directive (EU) 2016/680. These market surveillance activities will not interfere with the independence of judicial authorities or their judicial functions.
For
Union institutions, bodies, offices, or agencies covered by this
Regulation, the
European Data Protection Supervisor will serve as the
market surveillance authority, except for the
Court of Justice of the European Union when it is acting in its judicial capacity.
Member States must help coordinate between the designated
market surveillance authorities and other relevant
national authorities that oversee the application of
Union harmonization legislation listed in
Annex I or other
Union laws related to
high-risk AI systems mentioned in
Annex III.
Market surveillance authorities and the
Commission can propose joint activities, including joint investigations, to ensure compliance, identify non-compliance, raise awareness, or provide guidance regarding this
Regulation for
specific high-risk AI systems that pose serious risks across multiple
Member States, as outlined in
Article 9 of
Regulation (EU) 2019/1020. The
AI Office will support coordination for these joint investigations.
shall designate as market surveillance authorities for the purposes of
this Regulation either the competent data protection supervisory authorities under Regulation (EU) 2016/679 or Directive
(EU) 2016/680, or any other authority designated pursuant to the same conditions laid down in Articles 41 to 44 of
Directive (EU) 2016/680. Market surveillance activities shall in no way affect the independence of judicial authorities, or
otherwise interfere with their activities when acting in their judicial capacity.
9.
Where Union institutions, bodies, offices or agencies fall within the scope of this Regulation, the European Data
Protection Supervisor shall act as their market surveillance authority, except in relation to the Court of Justice of the
European Union acting in its judicial capacity.
10.
Member States shall facilitate coordination between market surveillance authorities designated under this Regulation
and other relevant national authorities or bodies which supervise the application of Union harmonisation legislation listed
in Annex I, or in other Union law, that might be relevant for the high-risk AI systems referred to in Annex III.
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11.
Market surveillance authorities and the Commission shall be able to propose joint activities, including joint
investigations, to be conducted by either market surveillance authorities or market surveillance authorities jointly with the
Commission, that have the aim of promoting compliance, identifying non-compliance, raising awareness or providing
guidance in relation to this Regulation with respect to specific categories of high-risk AI systems that are found to present
a serious risk across two or more Member States in accordance with Article 9 of Regulation (EU) 2019/1020. The AI Office
shall provide coordination support for joint investigations.
12.
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-risk AI systems that are found to present
a serious risk across two or more Member States in accordance with Article 9 of Regulation (EU) 2019/1020. The AI Office
shall provide coordination support for joint investigations.
12.
Without prejudice to the powers provided for under Regulation (EU) 2019/1020, and where relevant and limited to
what is necessary to fulfil their tasks, the market surveillance authorities shall be granted full access by providers to the
documentation as well as the training, validation and testing data sets used for the development of high-risk AI systems,
including, where appropriate and subject to security safeguards, through application programming interfaces (API) or other
relevant technical means and tools enabling remote access.
13.
Market surveillance authorities shall be granted access to the source code of the high-risk AI system upon a reasoned
request and only when both of the following conditions are fulfilled:
(a) access to source code is necessary to assess the conformity of a high-risk AI system with the requirements set out in
Chapter III, Section 2; and
(b) testing or auditing procedures and verifications based on the data and documentation provided by the provider have
been exhausted or proved insufficient.
14.
Any information or documentation obtained by market surveillance authorities shall be treated in accordance with
the confidentiality obligations set out in Article 78.
Article 75
Mutual assistance, market surveillance and control of general-purpose AI systems
1.
Where an AI system is based on a general-purpose AI model, and the model and the system are developed by the
same provider, the AI Office shall have powers to monitor and supervise compliance of that AI system with obligations
under this Regulation. To carry out its monitoring and supervision tasks, the AI Office shall have all the powers of a market
surveillance authority provided for in this Section and Regulation (EU) 2019/1020.
2.
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with obligations
under this Regulation. To carry out its monitoring and supervision tasks, the AI Office shall have all the powers of a market
surveillance authority provided for in this Section and Regulation (EU) 2019/1020.
2.
Where the relevant market surveillance authorities have sufficient reason to consider general-purpose AI systems that
can be used directly by deployers for at least one purpose that is classified as high-risk pursuant to this Regulation to be
non-compliant with the requirements laid down in this Regulation, they shall cooperate with the AI Office to carry out
compliance evaluations, and shall inform the Board and other market surveillance authorities accordingly.
3.
Where a market surveillance authority is unable to conclude its investigation of the high-risk AI system because of its
inability to access certain information related to the general-purpose AI model despite having made all appropriate efforts
to obtain that information, it may submit a reasoned request to the AI Office, by which access to that information shall be
enforced. In that case, the AI Office shall supply to the applicant authority without delay, and in any event within 30 days,
any information that the AI Office considers to be relevant in order to establish whether a high-risk AI system is
non-compliant. Market surveillance authorities shall safeguard the confidentiality of the information that they obtain in
accordance with Article 78 of this Regulation. The procedure provided for in Chapter VI of Regulation (EU) 2019/1020
shall apply mutatis mutandis.
Article 76
Supervision of testing in real world conditions by market surveillance authorities
1.
Market surveillance authorities shall have competences and powers to ensure that testing in real world conditions is in
accordance with this Regulation.
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2.
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According to this
regulation, when
AI systems are tested in real-world conditions within an
AI regulatory sandbox as outlined in
Article 58,
market surveillance authorities will check for compliance with
Article 60 as part of their oversight. These authorities may allow the
provider or potential
provider to conduct real-world testing, even if it doesn't fully meet the conditions in
Article 60(4), points (f) and (g). If a
market surveillance authority learns from the
provider, potential
provider, or a
third party about a
serious incident, or if they believe the conditions in Articles 60 and 61 are not being met, they can decide to either: (a) suspend or end the real-world testing, or (b) require changes to the testing process. If a
market surveillance authority makes such a decision or raises an objection as per
Article 60(4), point (b), they must explain the reasons for their decision and how the
provider can appeal it. Additionally, if applicable, the authority must inform other
Member States'
market surveillance authorities about the reasons for their decision if the
AI system has been tested in those countries according to the testing plan.
in
accordance with this Regulation.
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2.
Where testing in real world conditions is conducted for AI systems that are supervised within an AI regulatory
sandbox under Article 58, the market surveillance authorities shall verify the compliance with Article 60 as part of their
supervisory role for the AI regulatory sandbox. Those authorities may, as appropriate, allow the testing in real world
conditions to be conducted by the provider or prospective provider, in derogation from the conditions set out in Article
60(4), points (f) and (g).
3.
Where a market surveillance authority has been informed by the prospective provider, the provider or any third party
of a serious incident or has other grounds for considering that the conditions set out in Articles 60 and 61 are not met, it
may take either of the following decisions on its territory, as appropriate:
(a) to suspend or terminate the testing in real world conditions;
(b) to require the provider or prospective provider and the deployer or prospective deployer to modify any aspect of the
testing in real world conditions.
4.
Where a market surveillance authority has taken a decision referred to in paragraph 3 of this Article, or has issued an
objection within the meaning of Article 60(4), point (b), the decision or the objection shall indicate the grounds therefor
and how the provider or prospective provider can challenge the decision or objection.
5.
Where applicable, where a market surveillance authority has taken a decision referred to in paragraph 3, it shall
communicate the grounds therefor to the market surveillance authorities of other Member States in which the AI system
has been tested in accordance with the testing plan.
Article 77
Powers of authorities protecting fundamental rights
1.
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3, it shall
communicate the grounds therefor to the market surveillance authorities of other Member States in which the AI system
has been tested in accordance with the testing plan.
Article 77
Powers of authorities protecting fundamental rights
1.
National public authorities or bodies which supervise or enforce the respect of obligations under Union law
protecting fundamental rights, including the right to non-discrimination, in relation to the use of high-risk AI systems
referred to in Annex III shall have the power to request and access any documentation created or maintained under this
Regulation in accessible language and format when access to that documentation is necessary for effectively fulfilling their
mandates within the limits of their jurisdiction. The relevant public authority or body shall inform the market surveillance
authority of the Member State concerned of any such request.
2.
By 2 November 2024, each Member State shall identify the public authorities or bodies referred to in paragraph 1 and
make a list of them publicly available. Member States shall notify the list to the Commission and to the other Member
States, and shall keep the list up to date.
3.
Where the documentation referred to in paragraph 1 is insufficient to ascertain whether an infringement of
obligations under Union law protecting fundamental rights has occurred, the public authority or body referred to in
paragraph 1 may make a reasoned request to the market surveillance authority, to organise testing of the high-risk AI
system through technical means. The market surveillance authority shall organise the testing with the close involvement of
the requesting public authority or body within a reasonable time following the request.
4.
Any information or documentation obtained by the national public authorities or bodies referred to in paragraph 1 of
this Article pursuant to this Article shall be treated in accordance with the confidentiality obligations set out in Article 78.
Article 78
Confidentiality
1.
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Any information or documents obtained by
national public authorities mentioned in paragraph 1 of this Article must be handled according to the confidentiality rules outlined in
Article 78.
Article 78 - Confidentiality
1. The
Commission,
market surveillance authorities,
notified bodies, and any other individuals or organizations involved in enforcing this
Regulation must keep information and
data confidential, as required by
Union or national law. This confidentiality is especially important for:
(a) protecting
intellectual property rights and
confidential business information, including
trade secrets and source code, except in specific cases mentioned in
Article 5 of
Directive (EU) 2016/943;
(b) ensuring the effective enforcement of this
Regulation, particularly during inspections, investigations, or audits;
(c) safeguarding public and national security;
(d) managing criminal or administrative proceedings;
(e) handling classified information under
Union or national law.
2. The authorities applying this
Regulation will only request
data that is essential for assessing the risks of
AI systems and for exercising their powers under this
Regulation and
Regulation (EU) 2019/1020. They will implement strong
cybersecurity measures to protect the confidentiality and security of the information collected and will delete any
data as soon as it is no longer needed, following applicable
Union or national laws.
3.
or documentation obtained by the national public authorities or bodies referred to in paragraph 1 of
this Article pursuant to this Article shall be treated in accordance with the confidentiality obligations set out in Article 78.
Article 78
Confidentiality
1.
The Commission, market surveillance authorities and notified bodies and any other natural or legal person involved
in the application of this Regulation shall, in accordance with Union or national law, respect the confidentiality of
information and data obtained in carrying out their tasks and activities in such a manner as to protect, in particular:
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(a) the intellectual property rights and confidential business information or trade secrets of a natural or legal person,
including source code, except in the cases referred to in Article 5 of Directive (EU) 2016/943 of the European
Parliament and of the Council (57);
(b) the effective implementation of this Regulation, in particular for the purposes of inspections, investigations or audits;
(c) public and national security interests;
(d) the conduct of criminal or administrative proceedings;
(e) information classified pursuant to Union or national law.
2.
The authorities involved in the application of this Regulation pursuant to paragraph 1 shall request only data that is
strictly necessary for the assessment of the risk posed by AI systems and for the exercise of their powers in accordance with
this Regulation and with Regulation (EU) 2019/1020. They shall put in place adequate and effective cybersecurity measures
to protect the security and confidentiality of the information and data obtained, and shall delete the data collected as soon
as it is no longer needed for the purpose for which it was obtained, in accordance with applicable Union or national law.
3.
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Measures will be taken to ensure the security and confidentiality of the information and
data collected. This
data will be deleted as soon as it is no longer needed, following applicable
Union or national laws.
Additionally, any confidential information shared between
national authorities or between these authorities and the
Commission cannot be disclosed without first consulting the originating authority and the
deployer. This is especially important when
high-risk AI systems, as mentioned in points 1, 6, or 7 of
Annex III, are used by
law enforcement, border control, immigration, or
asylum authorities, and when such disclosure could threaten public or national security. This information exchange will not include
sensitive operational data related to these authorities' activities.
If
law enforcement, immigration, or
asylum authorities provide
high-risk AI systems mentioned in points 1, 6, or 7 of
Annex III, the
technical documentation must remain on their premises. These authorities must allow
market surveillance authorities, as outlined in
Article 74(8) and (9), to access this documentation or obtain copies upon request. Only staff from the
market surveillance authority with the necessary security clearance can access this documentation or copies of it.
The rights and
obligations of the
Commission,
Member States, and their relevant authorities, as well as
notified bodies, regarding information exchange and warning dissemination, especially in cross-border cooperation, remain unchanged. This also does not affect the
obligations of the parties involved to provide information under the criminal laws of the
Member States.
measures
to protect the security and confidentiality of the information and data obtained, and shall delete the data collected as soon
as it is no longer needed for the purpose for which it was obtained, in accordance with applicable Union or national law.
3.
Without prejudice to paragraphs 1 and 2, information exchanged on a confidential basis between the national
competent authorities or between national competent authorities and the Commission shall not be disclosed without prior
consultation of the originating national competent authority and the deployer when high-risk AI systems referred to in
point 1, 6 or 7 of Annex III are used by law enforcement, border control, immigration or asylum authorities and when such
disclosure would jeopardise public and national security interests. This exchange of information shall not cover sensitive
operational data in relation to the activities of law enforcement, border control, immigration or asylum authorities.
When the law enforcement, immigration or asylum authorities are providers of high-risk AI systems referred to in point 1,
6 or 7 of Annex III, the technical documentation referred to in Annex IV shall remain within the premises of those
authorities. Those authorities shall ensure that the market surveillance authorities referred to in Article 74(8) and (9), as
applicable, can, upon request, immediately access the documentation or obtain a copy thereof. Only staff of the market
surveillance authority holding the appropriate level of security clearance shall be allowed to access that documentation or
any copy thereof.
4.
Paragraphs 1, 2 and 3 shall not affect the rights or obligations of the Commission, Member States and their relevant
authorities, as well as those of notified bodies, with regard to the exchange of information and the dissemination of
warnings, including in the context of cross-border cooperation, nor shall they affect the obligations of the parties concerned
to provide information under criminal law of the Member States.
5.
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notified bodies, with regard to the exchange of information and the dissemination of
warnings, including in the context of cross-border cooperation, nor shall they affect the obligations of the parties concerned
to provide information under criminal law of the Member States.
5.
The Commission and Member States may exchange, where necessary and in accordance with relevant provisions of
international and trade agreements, confidential information with regulatory authorities of third countries with which they
have concluded bilateral or multilateral confidentiality arrangements guaranteeing an adequate level of confidentiality.
Article 79
Procedure at national level for dealing with AI systems presenting a risk
1.
AI systems presenting a risk shall be understood as a ‘product presenting a risk’ as defined in Article 3, point 19 of
Regulation (EU) 2019/1020, in so far as they present risks to the health or safety, or to fundamental rights, of persons.
2.
Where the market surveillance authority of a Member State has sufficient reason to consider an AI system to present
a risk as referred to in paragraph 1 of this Article, it shall carry out an evaluation of the AI system concerned in respect of
its compliance with all the requirements and obligations laid down in this Regulation. Particular attention shall be given to
AI systems presenting a risk to vulnerable groups. Where risks to fundamental rights are identified, the market surveillance
authority shall also inform and fully cooperate with the relevant national public authorities or bodies referred to in Article
77(1). The relevant operators shall cooperate as necessary with the market surveillance authority and with the other
national public authorities or bodies referred to in Article 77(1).
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According to
Article 77(1), relevant operators must work together with the
market surveillance authority and other
national public authorities mentioned in the same article.
Directive (EU) 2016/943, established on June 8, 2016, protects
trade secrets from illegal acquisition, use, and disclosure.
If the
market surveillance authority, or the authority working with it, finds that an
AI system does not meet the required standards, it must quickly instruct the
operator to take corrective actions. This could include making the
AI system compliant, withdrawing it from the market, or recalling it within a specified time frame, which cannot exceed 15 working days or the time set by relevant EU legislation. The
market surveillance authority will notify the appropriate body about these actions.
If the authority believes the non-compliance issue affects more than just its own country, it must promptly inform the
European Commission and other
Member States about the evaluation results and the required actions.
to in Article
77(1). The relevant operators shall cooperate as necessary with the market surveillance authority and with the other
national public authorities or bodies referred to in Article 77(1).
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(57)
Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how
and business information (trade secrets) against their unlawful acquisition, use and disclosure (OJ L 157, 15.6.2016, p. 1).
Where, in the course of that evaluation, the market surveillance authority or, where applicable the market surveillance
authority in cooperation with the national public authority referred to in Article 77(1), finds that the AI system does not
comply with the requirements and obligations laid down in this Regulation, it shall without undue delay require the relevant
operator to take all appropriate corrective actions to bring the AI system into compliance, to withdraw the AI system from
the market, or to recall it within a period the market surveillance authority may prescribe, and in any event within the
shorter of 15 working days, or as provided for in the relevant Union harmonisation legislation.
The market surveillance authority shall inform the relevant notified body accordingly. Article 18 of Regulation (EU)
2019/1020 shall apply to the measures referred to in the second subparagraph of this paragraph.
3.
Where the market surveillance authority considers that the non-compliance is not restricted to its national territory, it
shall inform the Commission and the other Member States without undue delay of the results of the evaluation and of the
actions which it has required the operator to take.
4.
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If a country finds that an
AI system is not compliant with regulations, it must quickly inform the
European Commission and other
Member States about the evaluation results and the actions it has required from the
operator. The
operator is responsible for taking corrective actions for all
AI systems it has made available in the EU market. If the
operator fails to take adequate corrective action within the specified time, the
market surveillance authority can take necessary temporary measures. These measures may include prohibiting or restricting the
AI system's availability in the national market, withdrawing the product, or recalling it. The authority must promptly notify the
Commission and other
Member States about these actions. This notification should include details such as the identification of the non-compliant
AI system, its origin, the supply chain, the nature of the non-compliance, the risks involved, the duration of the national measures taken, and the
operator's arguments. The
market surveillance authorities should specify if the non-compliance is due to: (a) violations of
prohibited AI practices, (b) a
high-risk AI system not meeting required standards, (c) issues with harmonized standards or specifications, or (d) violations of
Article 50.
considers that the non-compliance is not restricted to its national territory, it
shall inform the Commission and the other Member States without undue delay of the results of the evaluation and of the
actions which it has required the operator to take.
4.
The operator shall ensure that all appropriate corrective action is taken in respect of all the AI systems concerned that
it has made available on the Union market.
5.
Where the operator of an AI system does not take adequate corrective action within the period referred to in
paragraph 2, the market surveillance authority shall take all appropriate provisional measures to prohibit or restrict the AI
system’s being made available on its national market or put into service, to withdraw the product or the standalone AI
system from that market or to recall it. That authority shall without undue delay notify the Commission and the other
Member States of those measures.
6.
The notification referred to in paragraph 5 shall include all available details, in particular the information necessary
for the identification of the non-compliant AI system, the origin of the AI system and the supply chain, the nature of the
non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments
put forward by the relevant operator. In particular, the market surveillance authorities shall indicate whether the
non-compliance is due to one or more of the following:
(a) non-compliance with the prohibition of the AI practices referred to in Article 5;
(b) a failure of a high-risk AI system to meet requirements set out in Chapter III, Section 2;
(c) shortcomings in the harmonised standards or common specifications referred to in Articles 40 and 41 conferring
a presumption of conformity;
(d) non-compliance with Article 50.
7.
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set out in Chapter III, Section 2;
(c) shortcomings in the harmonised standards or common specifications referred to in Articles 40 and 41 conferring
a presumption of conformity;
(d) non-compliance with Article 50.
7.
The market surveillance authorities other than the market surveillance authority of the Member State initiating the
procedure shall, without undue delay, inform the Commission and the other Member States of any measures adopted and of
any additional information at their disposal relating to the non-compliance of the AI system concerned, and, in the event of
disagreement with the notified national measure, of their objections.
8.
Where, within three months of receipt of the notification referred to in paragraph 5 of this Article, no objection has
been raised by either a market surveillance authority of a Member State or by the Commission in respect of a provisional
measure taken by a market surveillance authority of another Member State, that measure shall be deemed justified. This
shall be without prejudice to the procedural rights of the concerned operator in accordance with Article 18 of Regulation
(EU) 2019/1020. The three-month period referred to in this paragraph shall be reduced to 30 days in the event of
non-compliance with the prohibition of the AI practices referred to in Article 5 of this Regulation.
9.
The market surveillance authorities shall ensure that appropriate restrictive measures are taken in respect of the
product or the AI system concerned, such as withdrawal of the product or the AI system from their market, without undue
delay.
Article 80
Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III
1.
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If a
market surveillance authority believes that an
AI system, which the
provider classified as non-high-risk, is actually high-risk, it will evaluate the system based on the criteria in
Article 6(3) and the
Commission's guidelines. If the authority determines that the
AI system is indeed high-risk, it will promptly require the
provider to take necessary actions to ensure compliance with the regulations and to implement corrective measures within a specified timeframe. If the
AI system's use extends beyond the national territory, the authority will inform the
Commission and other
Member States about the evaluation results and the required actions. The
provider must ensure compliance with the regulations. If the
provider fails to comply within the given timeframe, they may face fines as outlined in
Article 99.
the AI system concerned, such as withdrawal of the product or the AI system from their market, without undue
delay.
Article 80
Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III
1.
Where a market surveillance authority has sufficient reason to consider that an AI system classified by the provider as
non-high-risk pursuant to Article 6(3) is indeed high-risk, the market surveillance authority shall carry out an evaluation of
the AI system concerned in respect of its classification as a high-risk AI system based on the conditions set out in Article
6(3) and the Commission guidelines.
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2.
Where, in the course of that evaluation, the market surveillance authority finds that the AI system concerned is
high-risk, it shall without undue delay require the relevant provider to take all necessary actions to bring the AI system into
compliance with the requirements and obligations laid down in this Regulation, as well as take appropriate corrective action
within a period the market surveillance authority may prescribe.
3.
Where the market surveillance authority considers that the use of the AI system concerned is not restricted to its
national territory, it shall inform the Commission and the other Member States without undue delay of the results of the
evaluation and of the actions which it has required the provider to take.
4.
The provider shall ensure that all necessary action is taken to bring the AI system into compliance with the
requirements and obligations laid down in this Regulation. Where the provider of an AI system concerned does not bring
the AI system into compliance with those requirements and obligations within the period referred to in paragraph 2 of this
Article, the provider shall be subject to fines in accordance with Article 99.
5.
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provider of an AI system concerned does not bring
the AI system into compliance with those requirements and obligations within the period referred to in paragraph 2 of this
Article, the provider shall be subject to fines in accordance with Article 99.
5.
The provider shall ensure that all appropriate corrective action is taken in respect of all the AI systems concerned that
it has made available on the Union market.
6.
Where the provider of the AI system concerned does not take adequate corrective action within the period referred to
in paragraph 2 of this Article, Article 79(5) to (9) shall apply.
7.
Where, in the course of the evaluation pursuant to paragraph 1 of this Article, the market surveillance authority
establishes that the AI system was misclassified by the provider as non-high-risk in order to circumvent the application of
requirements in Chapter III, Section 2, the provider shall be subject to fines in accordance with Article 99.
8.
In exercising their power to monitor the application of this Article, and in accordance with Article 11 of Regulation
(EU) 2019/1020, market surveillance authorities may perform appropriate checks, taking into account in particular
information stored in the EU database referred to in Article 71 of this Regulation.
Article 81
Union safeguard procedure
1.
Where, within three months of receipt of the notification referred to in Article 79(5), or within 30 days in the case of
non-compliance with the prohibition of the AI practices referred to in Article 5, objections are raised by the market
surveillance authority of a Member State to a measure taken by another market surveillance authority, or where the
Commission considers the measure to be contrary to Union law, the Commission shall without undue delay enter into
consultation with the market surveillance authority of the relevant Member State and the operator or operators, and shall
evaluate the national measure.
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or where the
Commission considers the measure to be contrary to Union law, the Commission shall without undue delay enter into
consultation with the market surveillance authority of the relevant Member State and the operator or operators, and shall
evaluate the national measure. On the basis of the results of that evaluation, the Commission shall, within six months, or
within 60 days in the case of non-compliance with the prohibition of the AI practices referred to in Article 5, starting from
the notification referred to in Article 79(5), decide whether the national measure is justified and shall notify its decision to
the market surveillance authority of the Member State concerned. The Commission shall also inform all other market
surveillance authorities of its decision.
2.
Where the Commission considers the measure taken by the relevant Member State to be justified, all Member States
shall ensure that they take appropriate restrictive measures in respect of the AI system concerned, such as requiring the
withdrawal of the AI system from their market without undue delay, and shall inform the Commission accordingly. Where
the Commission considers the national measure to be unjustified, the Member State concerned shall withdraw the measure
and shall inform the Commission accordingly.
3.
Where the national measure is considered justified and the non-compliance of the AI system is attributed to
shortcomings in the harmonised standards or common specifications referred to in Articles 40 and 41 of this Regulation,
the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012.
Article 82
Compliant AI systems which present a risk
1.
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According to
Articles 40 and 41 of this
Regulation, the
Commission will follow the procedure outlined in
Article 11 of
Regulation (EU) No 1025/2012.
Article 82: Risky Compliant
AI Systems
1. If, after evaluating under
Article 79 and consulting the relevant national authority mentioned in
Article 77(1), a
market surveillance authority in a
Member State finds that a
high-risk AI system complies with the
Regulation but still poses a risk to health, safety,
fundamental rights, or
public interest, it must require the
operator to take necessary actions to eliminate that risk promptly, within a specified timeframe.
2. The
provider or relevant
operator must ensure that corrective actions are taken for all affected
AI systems available in the EU market within the timeframe set by the
market surveillance authority.
3.
Member States must immediately notify the
Commission and other
Member States about any findings from paragraph 1. This notification should include all relevant details, such as the identification of the
AI system, its origin and supply chain, the nature of the risk, and the national measures taken.
4. The
Commission will promptly consult with the affected
Member States and relevant operators to assess the national measures implemented.
40 and 41 of this Regulation,
the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012.
Article 82
Compliant AI systems which present a risk
1.
Where, having performed an evaluation under Article 79, after consulting the relevant national public authority
referred to in Article 77(1), the market surveillance authority of a Member State finds that although a high-risk AI system
complies with this Regulation, it nevertheless presents a risk to the health or safety of persons, to fundamental rights, or to
other aspects of public interest protection, it shall require the relevant operator to take all appropriate measures to ensure
that the AI system concerned, when placed on the market or put into service, no longer presents that risk without undue
delay, within a period it may prescribe.
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2.
The provider or other relevant operator shall ensure that corrective action is taken in respect of all the AI systems
concerned that it has made available on the Union market within the timeline prescribed by the market surveillance
authority of the Member State referred to in paragraph 1.
3.
The Member States shall immediately inform the Commission and the other Member States of a finding under
paragraph 1. That information shall include all available details, in particular the data necessary for the identification of the
AI system concerned, the origin and the supply chain of the AI system, the nature of the risk involved and the nature and
duration of the national measures taken.
4.
The Commission shall without undue delay enter into consultation with the Member States concerned and the
relevant operators, and shall evaluate the national measures taken.
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system, the nature of the risk involved and the nature and
duration of the national measures taken.
4.
The Commission shall without undue delay enter into consultation with the Member States concerned and the
relevant operators, and shall evaluate the national measures taken. On the basis of the results of that evaluation, the
Commission shall decide whether the measure is justified and, where necessary, propose other appropriate measures.
5.
The Commission shall immediately communicate its decision to the Member States concerned and to the relevant
operators. It shall also inform the other Member States.
Article 83
Formal non-compliance
1.
Where the market surveillance authority of a Member State makes one of the following findings, it shall require the
relevant provider to put an end to the non-compliance concerned, within a period it may prescribe:
(a) the CE marking has been affixed in violation of Article 48;
(b) the CE marking has not been affixed;
(c) the EU declaration of conformity referred to in Article 47 has not been drawn up;
(d) the EU declaration of conformity referred to in Article 47 has not been drawn up correctly;
(e) the registration in the EU database referred to in Article 71 has not been carried out;
(f) where applicable, no authorised representative has been appointed;
(g) technical documentation is not available.
2.
Where the non-compliance referred to in paragraph 1 persists, the market surveillance authority of the Member State
concerned shall take appropriate and proportionate measures to restrict or prohibit the high-risk AI system being made
available on the market or to ensure that it is recalled or withdrawn from the market without delay.
Article 84
Union AI testing support structures
1.
The Commission shall designate one or more Union AI testing support structures to perform the tasks listed under
Article 21(6) of Regulation (EU) 2019/1020 in the area of AI.
2.
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testing support structures
1.
The Commission shall designate one or more Union AI testing support structures to perform the tasks listed under
Article 21(6) of Regulation (EU) 2019/1020 in the area of AI.
2.
Without prejudice to the tasks referred to in paragraph 1, Union AI testing support structures shall also provide
independent technical or scientific advice at the request of the Board, the Commission, or of market surveillance authorities.
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SECTION 4
Remedies
Article 85
Right to lodge a complaint with a market surveillance authority
Without prejudice to other administrative or judicial remedies, any natural or legal person having grounds to consider that
there has been an infringement of the provisions of this Regulation may submit complaints to the relevant market
surveillance authority.
In accordance with Regulation (EU) 2019/1020, such complaints shall be taken into account for the purpose of conducting
market surveillance activities, and shall be handled in line with the dedicated procedures established therefor by the market
surveillance authorities.
Article 86
Right to explanation of individual decision-making
1.
Any affected person subject to a decision which is taken by the deployer on the basis of the output from a high-risk AI
system listed in Annex III, with the exception of systems listed under point 2 thereof, and which produces legal effects or
similarly significantly affects that person in a way that they consider to have an adverse impact on their health, safety or
fundamental rights shall have the right to obtain from the deployer clear and meaningful explanations of the role of the AI
system in the decision-making procedure and the main elements of the decision taken.
2.
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adverse impact on their health, safety or
fundamental rights shall have the right to obtain from the deployer clear and meaningful explanations of the role of the AI
system in the decision-making procedure and the main elements of the decision taken.
2.
Paragraph 1 shall not apply to the use of AI systems for which exceptions from, or restrictions to, the obligation
under that paragraph follow from Union or national law in compliance with Union law.
3.
This Article shall apply only to the extent that the right referred to in paragraph 1 is not otherwise provided for under
Union law.
Article 87
Reporting of infringements and protection of reporting persons
Directive (EU) 2019/1937 shall apply to the reporting of infringements of this Regulation and the protection of persons
reporting such infringements.
SECTION 5
Supervision, investigation, enforcement and monitoring in respect of providers of general-purpose AI models
Article 88
Enforcement of the obligations of providers of general-purpose AI models
1.
The Commission shall have exclusive powers to supervise and enforce Chapter V, taking into account the procedural
guarantees under Article 94. The Commission shall entrust the implementation of these tasks to the AI Office, without
prejudice to the powers of organisation of the Commission and the division of competences between Member States and
the Union based on the Treaties.
2.
Without prejudice to Article 75(3), market surveillance authorities may request the Commission to exercise the
powers laid down in this Section, where that is necessary and proportionate to assist with the fulfilment of their tasks under
this Regulation.
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Article 89
Monitoring actions
1.
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Regulation.
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Article 89
Monitoring actions
1.
For the purpose of carrying out the tasks assigned to it under this Section, the AI Office may take the necessary
actions to monitor the effective implementation and compliance with this Regulation by providers of general-purpose AI
models, including their adherence to approved codes of practice.
2.
Downstream providers shall have the right to lodge a complaint alleging an infringement of this Regulation.
A complaint shall be duly reasoned and indicate at least:
(a) the point of contact of the provider of the general-purpose AI model concerned;
(b) a description of the relevant facts, the provisions of this Regulation concerned, and the reason why the downstream
provider considers that the provider of the general-purpose AI model concerned infringed this Regulation;
(c) any other information that the downstream provider that sent the request considers relevant, including, where
appropriate, information gathered on its own initiative.
Article 90
Alerts of systemic risks by the scientific panel
1.
The scientific panel may provide a qualified alert to the AI Office where it has reason to suspect that:
(a) a general-purpose AI model poses concrete identifiable risk at Union level; or
(b) a general-purpose AI model meets the conditions referred to in Article 51.
2.
Upon such qualified alert, the Commission, through the AI Office and after having informed the Board, may exercise
the powers laid down in this Section for the purpose of assessing the matter. The AI Office shall inform the Board of any
measure according to Articles 91 to 94.
3.
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The
AI Office, after informing the
Board, can use its powers to evaluate the situation. It must notify the
Board of any actions taken according to
Articles 91 to 94. A qualified alert must include: (a) the contact information of the
provider of the
general-purpose AI model related to the
systemic risk; (b) a detailed explanation of the relevant facts and reasons for the alert from the
scientific panel; (c) any other relevant information the
scientific panel deems necessary, including any information it has gathered independently.
Article 91 outlines the
Commission's authority to request documentation and information: 1. The
Commission can ask the
provider of the
general-purpose AI model for documents created according to
Articles 53 and 55, or any additional information needed to assess compliance with this
Regulation. 2. Before making a request for information, the
AI Office may engage in a structured dialogue with the
provider. 3. If the
scientific panel makes a justified request, the
Commission can ask a
provider for information necessary for the panel's tasks under
Article 68(2).
4. The information request must include the legal basis and purpose of the request, specify the required information, set a deadline for submission, and mention the penalties outlined in
Article 101 for providing incorrect, incomplete, or misleading information.
the AI Office and after having informed the Board, may exercise
the powers laid down in this Section for the purpose of assessing the matter. The AI Office shall inform the Board of any
measure according to Articles 91 to 94.
3.
A qualified alert shall be duly reasoned and indicate at least:
(a) the point of contact of the provider of the general-purpose AI model with systemic risk concerned;
(b) a description of the relevant facts and the reasons for the alert by the scientific panel;
(c) any other information that the scientific panel considers to be relevant, including, where appropriate, information
gathered on its own initiative.
Article 91
Power to request documentation and information
1.
The Commission may request the provider of the general-purpose AI model concerned to provide the documentation
drawn up by the provider in accordance with Articles 53 and 55, or any additional information that is necessary for the
purpose of assessing compliance of the provider with this Regulation.
2.
Before sending the request for information, the AI Office may initiate a structured dialogue with the provider of the
general-purpose AI model.
3.
Upon a duly substantiated request from the scientific panel, the Commission may issue a request for information to
a provider of a general-purpose AI model, where the access to information is necessary and proportionate for the fulfilment
of the tasks of the scientific panel under Article 68(2).
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4.
The request for information shall state the legal basis and the purpose of the request, specify what information is
required, set a period within which the information is to be provided, and indicate the fines provided for in Article 101 for
supplying incorrect, incomplete or misleading information.
5.
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The request must clearly state the reason for the information needed, specify what information is required, set a deadline for providing this information, and mention the penalties outlined in
Article 101 for giving incorrect, incomplete, or misleading information.
The
provider of the
general-purpose AI model, or their representative, must supply the requested information. If the
provider is a legal entity, such as a company or firm, or lacks legal personality, the individuals authorized by law or their governing documents must provide the information on behalf of the
provider. Authorized lawyers can also supply information for their clients, but the clients remain fully responsible for any incomplete, incorrect, or misleading information provided.
Article 92 outlines the
AI Office's authority to conduct evaluations:
1. The
AI Office, after consulting the
Board, can evaluate the
general-purpose AI model to:
(a) check if the
provider is complying with regulations when the information from
Article 91 is insufficient, or
(b) investigate
systemic risks associated with
general-purpose AI models, especially after a qualified alert from the
scientific panel as per
Article 90(1)(a).
2. The
Commission may appoint independent experts, including those from the
scientific panel established in
Article 68, to conduct these evaluations. These experts must meet the criteria specified in
Article 68(2).
3. To carry out evaluations, the
Commission may request access to the
general-purpose AI model through APIs or other technical means, including the source code.
4. The access request must include the legal basis, purpose, reasons for the request, a deadline for providing access, and mention the penalties in
Article 101 for not providing access.
basis and the purpose of the request, specify what information is
required, set a period within which the information is to be provided, and indicate the fines provided for in Article 101 for
supplying incorrect, incomplete or misleading information.
5.
The provider of the general-purpose AI model concerned, or its representative shall supply the information requested.
In the case of legal persons, companies or firms, or where the provider has no legal personality, the persons authorised to
represent them by law or by their statutes, shall supply the information requested on behalf of the provider of the
general-purpose AI model concerned. Lawyers duly authorised to act may supply information on behalf of their clients. The
clients shall nevertheless remain fully responsible if the information supplied is incomplete, incorrect or misleading.
Article 92
Power to conduct evaluations
1.
The AI Office, after consulting the Board, may conduct evaluations of the general-purpose AI model concerned:
(a) to assess compliance of the provider with obligations under this Regulation, where the information gathered pursuant
to Article 91 is insufficient; or
(b) to investigate systemic risks at Union level of general-purpose AI models with systemic risk, in particular following
a qualified alert from the scientific panel in accordance with Article 90(1), point (a).
2.
The Commission may decide to appoint independent experts to carry out evaluations on its behalf, including from the
scientific panel established pursuant to Article 68. Independent experts appointed for this task shall meet the criteria
outlined in Article 68(2).
3.
For the purposes of paragraph 1, the Commission may request access to the general-purpose AI model concerned
through APIs or further appropriate technical means and tools, including source code.
4.
The request for access shall state the legal basis, the purpose and reasons of the request and set the period within
which the access is to be provided, and the fines provided for in Article 101 for failure to provide access.
5.
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4. A request for access must include the legal basis, purpose, reasons for the request, the timeframe for providing access, and mention the fines outlined in
Article 101 for not granting access. 5. The
providers of the
general-purpose AI model or their representatives must provide the requested information. If the
provider is a legal entity, such as a company, the authorized representatives must fulfill the request on behalf of the
provider. 6. The
Commission will create detailed rules and conditions for evaluations, including how to involve independent experts and the selection process for them. These rules will follow the examination procedure mentioned in
Article 98(2). 7. Before requesting access to the
AI model, the
AI Office may have a structured discussion with the
provider to learn more about the model's internal testing,
safeguards against
systemic risks, and other measures taken to address these risks.
Article 93 Power to request measures 1. If necessary, the
Commission may ask
providers to: (a) take appropriate actions to meet the
obligations in Articles 53 and 54; (b) implement measures to address serious concerns about
systemic risks identified in the evaluation under
Article 92; (c) limit market availability, withdraw, or recall the model.
4.
The request for access shall state the legal basis, the purpose and reasons of the request and set the period within
which the access is to be provided, and the fines provided for in Article 101 for failure to provide access.
5.
The providers of the general-purpose AI model concerned or its representative shall supply the information requested.
In the case of legal persons, companies or firms, or where the provider has no legal personality, the persons authorised to
represent them by law or by their statutes, shall provide the access requested on behalf of the provider of the
general-purpose AI model concerned.
6.
The Commission shall adopt implementing acts setting out the detailed arrangements and the conditions for the
evaluations, including the detailed arrangements for involving independent experts, and the procedure for the selection
thereof. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article
98(2).
7.
Prior to requesting access to the general-purpose AI model concerned, the AI Office may initiate a structured dialogue
with the provider of the general-purpose AI model to gather more information on the internal testing of the model, internal
safeguards for preventing systemic risks, and other internal procedures and measures the provider has taken to mitigate
such risks.
Article 93
Power to request measures
1.
Where necessary and appropriate, the Commission may request providers to:
(a) take appropriate measures to comply with the obligations set out in Articles 53 and 54;
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(b) implement mitigation measures, where the evaluation carried out in accordance with Article 92 has given rise to serious
and substantiated concern of a systemic risk at Union level;
(c) restrict the making available on the market, withdraw or recall the model.
2.
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If an evaluation under
Article 92 shows serious concerns about
systemic risks at the
Union level, mitigation measures may be taken, which could include limiting the availability of the
AI model, withdrawing it from the market, or recalling it. Before taking action, the
AI Office can start a structured dialogue with the
provider of the
general-purpose AI model. If during this dialogue the
provider offers to implement measures to address the
systemic risk, the
Commission can make these commitments binding and decide that no further action is needed.
Article 94 states that the procedural rights outlined in
Article 18 of Regulation (EU) 2019/1020 apply to
providers of
general-purpose AI models, along with any specific rights mentioned in this
Regulation.
In Chapter X, Article 95 discusses
codes of conduct for voluntary compliance with specific requirements. The
AI Office and
Member States will promote and support the creation of these codes, which aim to encourage the voluntary application of some or all requirements from
Chapter III, Section 2, for
AI systems that are not classified as high-risk, considering available
technical solutions and industry best practices.
mitigation measures, where the evaluation carried out in accordance with Article 92 has given rise to serious
and substantiated concern of a systemic risk at Union level;
(c) restrict the making available on the market, withdraw or recall the model.
2.
Before a measure is requested, the AI Office may initiate a structured dialogue with the provider of the
general-purpose AI model.
3.
If, during the structured dialogue referred to in paragraph 2, the provider of the general-purpose AI model with
systemic risk offers commitments to implement mitigation measures to address a systemic risk at Union level, the
Commission may, by decision, make those commitments binding and declare that there are no further grounds for action.
Article 94
Procedural rights of economic operators of the general-purpose AI model
Article 18 of Regulation (EU) 2019/1020 shall apply mutatis mutandis to the providers of the general-purpose AI model,
without prejudice to more specific procedural rights provided for in this Regulation.
CHAPTER X
CODES OF CONDUCT AND GUIDELINES
Article 95
Codes of conduct for voluntary application of specific requirements
1.
The AI Office and the Member States shall encourage and facilitate the drawing up of codes of conduct, including
related governance mechanisms, intended to foster the voluntary application to AI systems, other than high-risk AI systems,
of some or all of the requirements set out in Chapter III, Section 2 taking into account the available technical solutions and
industry best practices allowing for the application of such requirements.
2.
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AI systems that are not classified as high-risk may be
subject to some or all requirements outlined in
Chapter III, Section 2, depending on available
technical solutions and industry best practices.
The
AI Office and
Member States will help create voluntary
codes of conduct for
AI systems. These codes will include specific requirements based on clear goals and
key performance indicators to measure success. Key elements may include:
(a) adherence to
Union ethical guidelines for trustworthy AI;
(b) evaluating and reducing the environmental impact of
AI systems, focusing on energy-efficient programming and design;
(c) promoting
AI literacy, especially for those involved in developing and using
AI;
(d) ensuring
inclusive and diverse design of
AI systems by forming diverse development teams and encouraging stakeholder participation;
(e) assessing and preventing negative impacts of
AI on
vulnerable groups, including ensuring accessibility for people with disabilities and promoting gender equality.
Codes of conduct can be created by individual
AI providers or deployers, organizations representing them, or both, with input from interested
stakeholders, including civil society and academia. These codes may apply to one or more
AI systems with similar purposes.
The
AI Office and
Member States will consider the specific needs of small and medium-sized enterprises (
SMEs), including
start-ups, when promoting the development of these codes.
to AI systems, other than high-risk AI systems,
of some or all of the requirements set out in Chapter III, Section 2 taking into account the available technical solutions and
industry best practices allowing for the application of such requirements.
2.
The AI Office and the Member States shall facilitate the drawing up of codes of conduct concerning the voluntary
application, including by deployers, of specific requirements to all AI systems, on the basis of clear objectives and key
performance indicators to measure the achievement of those objectives, including elements such as, but not limited to:
(a) applicable elements provided for in Union ethical guidelines for trustworthy AI;
(b) assessing and minimising the impact of AI systems on environmental sustainability, including as regards energy-efficient
programming and techniques for the efficient design, training and use of AI;
(c) promoting AI literacy, in particular that of persons dealing with the development, operation and use of AI;
(d) facilitating an inclusive and diverse design of AI systems, including through the establishment of inclusive and diverse
development teams and the promotion of stakeholders’ participation in that process;
(e) assessing and preventing the negative impact of AI systems on vulnerable persons or groups of vulnerable persons,
including as regards accessibility for persons with a disability, as well as on gender equality.
3.
Codes of conduct may be drawn up by individual providers or deployers of AI systems or by organisations
representing them or by both, including with the involvement of any interested stakeholders and their representative
organisations, including civil society organisations and academia. Codes of conduct may cover one or more AI systems
taking into account the similarity of the intended purpose of the relevant systems.
4.
The AI Office and the Member States shall take into account the specific interests and needs of SMEs, including
start-ups, when encouraging and facilitating the drawing up of codes of conduct.
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systems.
4.
The AI Office and the Member States shall take into account the specific interests and needs of SMEs, including
start-ups, when encouraging and facilitating the drawing up of codes of conduct.
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Article 96
Guidelines from the Commission on the implementation of this Regulation
1.
The Commission shall develop guidelines on the practical implementation of this Regulation, and in particular on:
(a) the application of the requirements and obligations referred to in Articles 8 to 15 and in Article 25;
(b) the prohibited practices referred to in Article 5;
(c) the practical implementation of the provisions related to substantial modification;
(d) the practical implementation of transparency obligations laid down in Article 50;
(e) detailed information on the relationship of this Regulation with the Union harmonisation legislation listed in Annex I,
as well as with other relevant Union law, including as regards consistency in their enforcement;
(f) the application of the definition of an AI system as set out in Article 3, point (1).
When issuing such guidelines, the Commission shall pay particular attention to the needs of SMEs including start-ups, of
local public authorities and of the sectors most likely to be affected by this Regulation.
The guidelines referred to in the first subparagraph of this paragraph shall take due account of the generally acknowledged
state of the art on AI, as well as of relevant harmonised standards and common specifications that are referred to in
Articles 40 and 41, or of those harmonised standards or technical specifications that are set out pursuant to Union
harmonisation law.
2.
At the request of the Member States or the AI Office, or on its own initiative, the Commission shall update guidelines
previously adopted when deemed necessary.
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The
Commission can create standards or technical specifications based on EU harmonization law. It can update existing guidelines when requested by
Member States, the
AI Office, or on its own initiative.
**Chapter XI: Delegation of Power and Committee Procedure**
**
Article 97: Exercise of the Delegation**
1. The
Commission has the authority to adopt delegated acts as outlined in this Article.
2. The
Commission can adopt delegated acts related to Articles 6(6), 6(7), 7(1), 7(3), 11(3), 43(5), 43(6), 47(5), 51(3), 52(4), and 53(5) and (6) for five years starting from August 1, 2024. It must report on this delegation of power no later than nine months before the five-year period ends. This delegation will automatically extend for the same duration unless the
European Parliament or the
Council objects at least three months before the end of each period.
3. The
European Parliament or the
Council can revoke this delegation of power at any time, which will end the specified delegation.
standards or technical specifications that are set out pursuant to Union
harmonisation law.
2.
At the request of the Member States or the AI Office, or on its own initiative, the Commission shall update guidelines
previously adopted when deemed necessary.
CHAPTER XI
DELEGATION OF POWER AND COMMITTEE PROCEDURE
Article 97
Exercise of the delegation
1.
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2.
The power to adopt delegated acts referred to in Article 6(6) and (7), Article 7(1) and (3), Article 11(3), Article 43(5)
and (6), Article 47(5), Article 51(3), Article 52(4) and Article 53(5) and (6) shall be conferred on the Commission for
a period of five years from 1 August 2024. The Commission shall draw up a report in respect of the delegation of power
not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for
periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three
months before the end of each period.
3.
The delegation of power referred to in Article 6(6) and (7), Article 7(1) and (3), Article 11(3), Article 43(5) and (6),
Article 47(5), Article 51(3), Article 52(4) and Article 53(5) and (6) may be revoked at any time by the European Parliament
or by the Council. A decision of revocation shall put an end to the delegation of power specified in that decision.
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The
European Parliament or the
Council can revoke Articles 52(4) and 53(5) and (6) at any time. When they revoke these articles, the power given in that decision will end. The revocation will take effect the day after it is published in the
Official Journal of the European Union or on a later specified date. This will not affect any delegated acts that are already in effect.
Before the
Commission adopts a delegated act, it must consult experts chosen by each
Member State, following the guidelines from the Interinstitutional Agreement on Better Law-Making dated April 13, 2016.
Once the
Commission adopts a delegated act, it must notify both the
European Parliament and the
Council at the same time.
A delegated act based on specific articles (
Article 6(6) or (7),
Article 7(1) or (3),
Article 11(3),
Article 43(5) or (6),
Article 47(5),
Article 51(3),
Article 52(4), or
Article 53(5) or (6)) will only take effect if neither the
European Parliament nor the
Council objects within three months of being notified. If both inform the
Commission before the three months are up that they will not object, the act will also take effect. This three-month period can be extended by another three months if either the
European Parliament or the
Council requests it.
Article 98 states that the
Commission will be supported by a committee.
52(4) and Article 53(5) and (6) may be revoked at any time by the European Parliament
or by the Council. A decision of revocation shall put an end to the delegation of power specified in that decision. It shall
take effect the day following that of its publication in the Official Journal of the European Union or at a later date specified
therein. It shall not affect the validity of any delegated acts already in force.
4.
Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance
with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
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5.
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to
the Council.
6.
Any delegated act adopted pursuant to Article 6(6) or (7), Article 7(1) or (3), Article 11(3), Article 43(5) or (6),
Article 47(5), Article 51(3), Article 52(4) or Article 53(5) or (6) shall enter into force only if no objection has been
expressed by either the European Parliament or the Council within a period of three months of notification of that act to
the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council
have both informed the Commission that they will not object. That period shall be extended by three months at the
initiative of the European Parliament or of the Council.
Article 98
Committee procedure
1.
The Commission shall be assisted by a committee.
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The
Commission has informed that they will not raise any objections. The period for this can be extended by three months if the
European Parliament or the
Council initiates it.
**
Article 98: Committee Procedure**
1. The
Commission will be supported by a committee, which is defined under
Regulation (EU) No 182/2011.
2. When this paragraph is referenced,
Article 5 of
Regulation (EU) No 182/2011 will apply.
**CHAPTER XII: PENALTIES**
**
Article 99: Penalties**
1.
Member States must establish rules for penalties and enforcement measures for violations of this
Regulation. These can include warnings and non-monetary actions. The penalties must be effective, proportionate, and discouraging, considering the interests of small and medium-sized enterprises (
SMEs) and their economic viability.
Member States must ensure these rules are properly implemented, following the guidelines from the
Commission as stated in
Article 96.
2.
Member States must promptly inform the
Commission about their penalty rules and any changes to them by the time this
Regulation comes into effect.
3. Violations of the
AI practices mentioned in
Article 5 can result in administrative fines of up to EUR 35,000,000 or, for companies, up to 7% of their total worldwide annual turnover from the previous financial year, whichever amount is higher.
informed the Commission that they will not object. That period shall be extended by three months at the
initiative of the European Parliament or of the Council.
Article 98
Committee procedure
1.
The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of
Regulation (EU) No 182/2011.
2.
Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
CHAPTER XII
PENALTIES
Article 99
Penalties
1.
In accordance with the terms and conditions laid down in this Regulation, Member States shall lay down the rules on
penalties and other enforcement measures, which may also include warnings and non-monetary measures, applicable to
infringements of this Regulation by operators, and shall take all measures necessary to ensure that they are properly and
effectively implemented, thereby taking into account the guidelines issued by the Commission pursuant to Article 96. The
penalties provided for shall be effective, proportionate and dissuasive. They shall take into account the interests of SMEs,
including start-ups, and their economic viability.
2.
The Member States shall, without delay and at the latest by the date of entry into application, notify the Commission
of the rules on penalties and of other enforcement measures referred to in paragraph 1, and shall notify it, without delay, of
any subsequent amendment to them.
3.
Non-compliance with the prohibition of the AI practices referred to in Article 5 shall be subject to administrative
fines of up to EUR 35 000 000 or, if the offender is an undertaking, up to 7 % of its total worldwide annual turnover for the
preceding financial year, whichever is higher.
4.
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Companies can face administrative fines of up to EUR 35,000,000 or, if they are a business, up to 7% of their total worldwide annual revenue from the previous financial year, whichever amount is higher, for serious violations.
For non-compliance with specific rules related to operators or
notified bodies (excluding those in
Article 5), fines can reach up to EUR 15,000,000 or, for businesses, up to 3% of their total worldwide annual revenue from the previous financial year, whichever is higher. These rules include
obligations for:
(a)
providers (
Article 16);
(b) authorized representatives (
Article 22);
(c) importers (Article 23);
(d) distributors (
Article 24);
(e) deployers (
Article 26);
(f)
notified bodies (Articles 31, 33(1), (3), (4), and 34);
(g)
transparency for
providers and deployers (
Article 50).
Providing incorrect, incomplete, or misleading information to
notified bodies or
national authorities can result in fines of up to EUR 7,500,000 or, for businesses, up to 1% of their total worldwide annual revenue from the previous financial year, whichever is higher.
For small and medium-sized enterprises (
SMEs), including
start-ups, the fines mentioned will be capped at the lower of the specified amounts or percentages in paragraphs 3, 4, and 5.
subject to administrative
fines of up to EUR 35 000 000 or, if the offender is an undertaking, up to 7 % of its total worldwide annual turnover for the
preceding financial year, whichever is higher.
4.
Non-compliance with any of the following provisions related to operators or notified bodies, other than those laid
down in Articles 5, shall be subject to administrative fines of up to EUR 15 000 000 or, if the offender is an undertaking, up
to 3 % of its total worldwide annual turnover for the preceding financial year, whichever is higher:
(a) obligations of providers pursuant to Article 16;
(b) obligations of authorised representatives pursuant to Article 22;
(c) obligations of importers pursuant to Article 23;
(d) obligations of distributors pursuant to Article 24;
(e) obligations of deployers pursuant to Article 26;
(f) requirements and obligations of notified bodies pursuant to Article 31, Article 33(1), (3) and (4) or Article 34;
(g) transparency obligations for providers and deployers pursuant to Article 50.
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5.
The supply of incorrect, incomplete or misleading information to notified bodies or national competent authorities in
reply to a request shall be subject to administrative fines of up to EUR 7 500 000 or, if the offender is an undertaking, up to
1 % of its total worldwide annual turnover for the preceding financial year, whichever is higher.
6.
In the case of SMEs, including start-ups, each fine referred to in this Article shall be up to the percentages or amount
referred to in paragraphs 3, 4 and 5, whichever thereof is lower.
7.
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6. For small and medium-sized enterprises (
SMEs) and
start-ups, any fines mentioned in this Article will be limited to the lower of the percentages or amounts specified in paragraphs 3, 4, and 5. 7. When deciding whether to impose a fine and determining its amount, all relevant factors of the situation will be considered, including: (a) the nature, seriousness, and duration of the violation and its effects, including the purpose of the
AI system and the number of people affected; (b) if other
market surveillance authorities have already fined the same
operator for the same violation; (c) if other authorities have fined the same
operator for different violations related to the same activity; (d) the size, annual revenue, and market share of the
operator; (e) any other factors that may increase or decrease the severity of the case, such as financial gains or losses avoided due to the violation; (f) the level of cooperation from the
operator with
national authorities to address the violation; (g) the
operator's responsibility based on the technical and organizational measures they have in place; (h) how the violation came to the attention of
national authorities, especially if the
operator reported it; (i) whether the violation was intentional or due to negligence; (j) any actions taken by the
operator to reduce the harm to affected individuals.
6.
In the case of SMEs, including start-ups, each fine referred to in this Article shall be up to the percentages or amount
referred to in paragraphs 3, 4 and 5, whichever thereof is lower.
7.
When deciding whether to impose an administrative fine and when deciding on the amount of the administrative fine
in each individual case, all relevant circumstances of the specific situation shall be taken into account and, as appropriate,
regard shall be given to the following:
(a) the nature, gravity and duration of the infringement and of its consequences, taking into account the purpose of the AI
system, as well as, where appropriate, the number of affected persons and the level of damage suffered by them;
(b) whether administrative fines have already been applied by other market surveillance authorities to the same operator for
the same infringement;
(c) whether administrative fines have already been applied by other authorities to the same operator for infringements of
other Union or national law, when such infringements result from the same activity or omission constituting a relevant
infringement of this Regulation;
(d) the size, the annual turnover and market share of the operator committing the infringement;
(e) any other aggravating or mitigating factor applicable to the circumstances of the case, such as financial benefits gained,
or losses avoided, directly or indirectly, from the infringement;
(f) the degree of cooperation with the national competent authorities, in order to remedy the infringement and mitigate the
possible adverse effects of the infringement;
(g) the degree of responsibility of the operator taking into account the technical and organisational measures implemented
by it;
(h) the manner in which the infringement became known to the national competent authorities, in particular whether, and
if so to what extent, the operator notified the infringement;
(i) the intentional or negligent character of the infringement;
(j) any action taken by the operator to mitigate the harm suffered by the affected persons.
8.
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The
operator must notify about the infringement, and the extent of this notification is important. Factors to consider include whether the infringement was intentional or negligent, and any actions taken by the
operator to reduce harm to affected individuals.
Each
Member State will establish rules regarding the imposition of administrative fines on
public authorities and bodies within that state. Depending on the legal system, these fines may be imposed by national courts or other relevant bodies, and the application of these rules should have similar effects across
Member States.
The enforcement of these rules must follow proper legal procedures, ensuring judicial remedies and due process are in place.
Member States are required to report annually to the
Commission about the administrative fines they have issued and any related legal proceedings.
According to
Article 100, the
European Data Protection Supervisor can impose administrative fines on
Union institutions, bodies, offices, and agencies covered by this
Regulation. When deciding on fines, all relevant circumstances must be considered, including the specifics of each case.
, in particular whether, and
if so to what extent, the operator notified the infringement;
(i) the intentional or negligent character of the infringement;
(j) any action taken by the operator to mitigate the harm suffered by the affected persons.
8.
Each Member State shall lay down rules on to what extent administrative fines may be imposed on public authorities
and bodies established in that Member State.
9.
Depending on the legal system of the Member States, the rules on administrative fines may be applied in such
a manner that the fines are imposed by competent national courts or by other bodies, as applicable in those Member States.
The application of such rules in those Member States shall have an equivalent effect.
10.
The exercise of powers under this Article shall be subject to appropriate procedural safeguards in accordance with
Union and national law, including effective judicial remedies and due process.
11.
Member States shall, on an annual basis, report to the Commission about the administrative fines they have issued
during that year, in accordance with this Article, and about any related litigation or judicial proceedings.
Article 100
Administrative fines on Union institutions, bodies, offices and agencies
1.
The European Data Protection Supervisor may impose administrative fines on Union institutions, bodies, offices and
agencies falling within the scope of this Regulation. When deciding whether to impose an administrative fine and when
deciding on the amount of the administrative fine in each individual case, all relevant circumstances of the specific situation
shall be taken into account and due regard shall be given to the following:
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When determining the amount of an
administrative fine for a specific case, all relevant circumstances must be considered, including: (a) the nature, seriousness, and duration of the violation, its consequences, the purpose of the
AI system involved, the number of people affected, and the level of damage they experienced; (b) the responsibility of the
Union institution, body, office, or agency, considering the technical and organizational measures they have taken; (c) any actions taken by the institution to reduce the damage to affected individuals; (d) the level of cooperation with the
European Data Protection Supervisor to address the violation and lessen its negative effects, including adherence to any previous measures ordered by the Supervisor regarding the same issue; (e) any similar past violations by the institution; (f) how the violation was discovered by the
European Data Protection Supervisor, especially whether and how the institution reported it; (g) the annual budget of the institution. Additionally, failing to comply with the
prohibited AI practices mentioned in
Article 5 may result in administrative fines of up to EUR 1,500,000.
when
deciding on the amount of the administrative fine in each individual case, all relevant circumstances of the specific situation
shall be taken into account and due regard shall be given to the following:
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(a) the nature, gravity and duration of the infringement and of its consequences, taking into account the purpose of the AI
system concerned, as well as, where appropriate, the number of affected persons and the level of damage suffered by
them;
(b) the degree of responsibility of the Union institution, body, office or agency, taking into account technical and
organisational measures implemented by them;
(c) any action taken by the Union institution, body, office or agency to mitigate the damage suffered by affected persons;
(d) the degree of cooperation with the European Data Protection Supervisor in order to remedy the infringement and
mitigate the possible adverse effects of the infringement, including compliance with any of the measures previously
ordered by the European Data Protection Supervisor against the Union institution, body, office or agency concerned
with regard to the same subject matter;
(e) any similar previous infringements by the Union institution, body, office or agency;
(f) the manner in which the infringement became known to the European Data Protection Supervisor, in particular
whether, and if so to what extent, the Union institution, body, office or agency notified the infringement;
(g) the annual budget of the Union institution, body, office or agency.
2.
Non-compliance with the prohibition of the AI practices referred to in Article 5 shall be subject to administrative
fines of up to EUR 1 500 000.
3.
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1.
Union institutions, bodies, offices, or agencies must comply with regulations regarding
AI practices. 2. If they violate the
AI practices outlined in
Article 5, they can face administrative fines of up to EUR 1,500,000. 3. For non-compliance with other requirements of this
Regulation, fines can be up to EUR 750,000. 4. Before making any decisions, the
European Data Protection Supervisor will allow the affected institution to present their case regarding the alleged violation. Decisions will be based only on information that both parties have had the chance to discuss. Complainants will also be involved in the process. 5. The rights of the parties involved will be fully respected, including access to the
European Data Protection Supervisor’s files, unless it conflicts with the protection of
personal data or business secrets. 6. Fines collected will go to the general budget of the
Union and will not hinder the operations of the fined institution. 7. The
European Data Protection Supervisor will inform the
Commission annually about the fines imposed and any related legal actions.
of the Union institution, body, office or agency.
2.
Non-compliance with the prohibition of the AI practices referred to in Article 5 shall be subject to administrative
fines of up to EUR 1 500 000.
3.
The non-compliance of the AI system with any requirements or obligations under this Regulation, other than those
laid down in Article 5, shall be subject to administrative fines of up to EUR 750 000.
4.
Before taking decisions pursuant to this Article, the European Data Protection Supervisor shall give the Union
institution, body, office or agency which is the subject of the proceedings conducted by the European Data Protection
Supervisor the opportunity of being heard on the matter regarding the possible infringement. The European Data
Protection Supervisor shall base his or her decisions only on elements and circumstances on which the parties concerned
have been able to comment. Complainants, if any, shall be associated closely with the proceedings.
5.
The rights of defence of the parties concerned shall be fully respected in the proceedings. They shall be entitled to
have access to the European Data Protection Supervisor’s file, subject to the legitimate interest of individuals or
undertakings in the protection of their personal data or business secrets.
6.
Funds collected by imposition of fines in this Article shall contribute to the general budget of the Union. The fines
shall not affect the effective operation of the Union institution, body, office or agency fined.
7.
The European Data Protection Supervisor shall, on an annual basis, notify the Commission of the administrative fines
it has imposed pursuant to this Article and of any litigation or judicial proceedings it has initiated.
Article 101
Fines for providers of general-purpose AI models
1.
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Each year, the Supervisor must inform the
Commission about any administrative fines it has imposed and any legal actions it has started.
**
Article 101: Fines for
Providers of
General-Purpose AI Models**
1. The
Commission can impose fines on
providers of
general-purpose AI models. These fines can be up to 3% of the
provider's total global revenue from the previous financial year or €15,000,000, whichever amount is higher, if the
provider:
(a) violates the rules of this
Regulation;
(b) does not comply with a request for documents or information as stated in
Article 91, or provides incorrect, incomplete, or misleading information;
(c) fails to follow a measure requested under
Article 93;
(d) does not allow the
Commission access to the
general-purpose AI model or a model with
systemic risk for evaluation as per
Article 92.
When determining the fine amount, the
Commission will consider the nature, seriousness, and duration of the violation, while ensuring the fine is fair and appropriate. The
Commission will also consider any commitments made under
Article 93(3) or relevant
codes of practice from
Article 56.
2. Before making a final decision, the
Commission will share its initial findings with the
provider and allow them to respond.
3. Fines must be effective, fair, and act as a deterrent.
4. Information about the fines will also be shared with the
Board as needed.
Supervisor shall, on an annual basis, notify the Commission of the administrative fines
it has imposed pursuant to this Article and of any litigation or judicial proceedings it has initiated.
Article 101
Fines for providers of general-purpose AI models
1.
The Commission may impose on providers of general-purpose AI models fines not exceeding 3 % of their annual total
worldwide turnover in the preceding financial year or EUR 15 000 000, whichever is higher., when the Commission finds
that the provider intentionally or negligently:
(a) infringed the relevant provisions of this Regulation;
(b) failed to comply with a request for a document or for information pursuant to Article 91, or supplied incorrect,
incomplete or misleading information;
(c) failed to comply with a measure requested under Article 93;
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(d) failed to make available to the Commission access to the general-purpose AI model or general-purpose AI model with
systemic risk with a view to conducting an evaluation pursuant to Article 92.
In fixing the amount of the fine or periodic penalty payment, regard shall be had to the nature, gravity and duration of the
infringement, taking due account of the principles of proportionality and appropriateness. The Commission shall also into
account commitments made in accordance with Article 93(3) or made in relevant codes of practice in accordance with
Article 56.
2.
Before adopting the decision pursuant to paragraph 1, the Commission shall communicate its preliminary findings to
the provider of the general-purpose AI model and give it an opportunity to be heard.
3.
Fines imposed in accordance with this Article shall be effective, proportionate and dissuasive.
4.
Information on fines imposed under this Article shall also be communicated to the Board as appropriate.
5.
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1. Parties should be given a chance to present their case. 2. Fines imposed under this Article must be effective, fair, and serve as a deterrent. 3. Information about these fines will be shared with the
Board as needed. 4. The
Court of Justice of the European Union can review the
Commission's decisions on fines, and it has the authority to cancel, reduce, or increase the fines. 5. The
Commission will create detailed rules and procedures for the decision-making process related to this Article, following the examination procedure outlined in
Article 98(2). 6. In
Article 4(3) of
Regulation (EC) No 300/2008, a new sentence will be added: 'When creating detailed measures for the technical specifications and procedures for the approval and use of security equipment related to
Artificial Intelligence systems, the requirements in
Chapter III, Section 2 of
Regulation (EU) 2024/1689 must be considered.' This
regulation was established on June 13, 2024, and it sets harmonized rules on artificial intelligence while amending several other regulations and directives.
give it an opportunity to be heard.
3.
Fines imposed in accordance with this Article shall be effective, proportionate and dissuasive.
4.
Information on fines imposed under this Article shall also be communicated to the Board as appropriate.
5.
The Court of Justice of the European Union shall have unlimited jurisdiction to review decisions of the Commission
fixing a fine under this Article. It may cancel, reduce or increase the fine imposed.
6.
The Commission shall adopt implementing acts containing detailed arrangements and procedural safeguards for
proceedings in view of the possible adoption of decisions pursuant to paragraph 1 of this Article. Those implementing acts
shall be adopted in accordance with the examination procedure referred to in Article 98(2).
CHAPTER XIII
FINAL PROVISIONS
Article 102
Amendment to Regulation (EC) No 300/2008
In Article 4(3) of Regulation (EC) No 300/2008, the following subparagraph is added:
‘When adopting detailed measures related to technical specifications and procedures for approval and use of security
equipment concerning Artificial Intelligence systems within the meaning of Regulation (EU) 2024/1689 of the European
Parliament and of the Council (*), the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into
account.
(*)
Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised
rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013,
(EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU)
2020/1828 (Art
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(EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU)
2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/
2024/1689/oj).’.
Article 103
Amendment to Regulation (EU) No 167/2013
In Article 17(5) of Regulation (EU) No 167/2013, the following subparagraph is added:
‘When adopting delegated acts pursuant to the first subparagraph concerning artificial intelligence systems which are safety
components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council (*), the
requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.
(*)
Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised
rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013,
(EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU)
2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/
2024/1689/oj).’.
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2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/
2024/1689/oj).’.
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Article 104
Amendment to Regulation (EU) No 168/2013
In Article 22(5) of Regulation (EU) No 168/2013, the following subparagraph is added:
‘When adopting delegated acts pursuant to the first subparagraph concerning Artificial Intelligence systems which are safety
components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council (*), the
requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.
(*)
Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised
rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013,
(EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU)
2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/
2024/1689/oj).’.
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(Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/
2024/1689/oj).’.
Article 105
Amendment to Directive 2014/90/EU
In Article 8 of Directive 2014/90/EU, the following paragraph is added:
‘5.
For Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of
the European Parliament and of the Council (*), when carrying out its activities pursuant to paragraph 1 and when adopting
technical specifications and testing standards in accordance with paragraphs 2 and 3, the Commission shall take into
account the requirements set out in Chapter III, Section 2, of that Regulation.
(*)
Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised
rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013,
(EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU)
2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/
2024/1689/oj).’.
Article 106
Amendment to Directive (EU) 2016/797
In Article 5 of Directive (EU) 2016/797, the following paragraph is added:
‘12.
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4/1689/oj).’.
Article 106
Amendment to Directive (EU) 2016/797
In Article 5 of Directive (EU) 2016/797, the following paragraph is added:
‘12.
When adopting delegated acts pursuant to paragraph 1 and implementing acts pursuant to paragraph 11
concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689
of the European Parliament and of the Council (*), the requirements set out in Chapter III, Section 2, of that Regulation shall
be taken into account.
(*)
Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised
rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013,
(EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU)
2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/
2024/1689/oj).’.
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Article 107
Amendment to Regulation (EU) 2018/858
In Article 5 of Regulation (EU) 2018/858 the following paragraph is added:
‘4.
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Article 107
Amendment to Regulation (EU) 2018/858
In Article 5 of Regulation (EU) 2018/858 the following paragraph is added:
‘4.
When adopting delegated acts pursuant to paragraph 3 concerning Artificial Intelligence systems which are safety
components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council (*), the
requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.
(*)
Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised
rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013,
(EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU)
2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/
2024/1689/oj).’.
Article 108
Amendments to Regulation (EU) 2018/1139
Regulation (EU) 2018/1139 is amended as follows:
(1) in Article 17, the following paragraph is added:
‘3.
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108
Amendments to Regulation (EU) 2018/1139
Regulation (EU) 2018/1139 is amended as follows:
(1) in Article 17, the following paragraph is added:
‘3.
Without prejudice to paragraph 2, when adopting implementing acts pursuant to paragraph 1 concerning
Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the
European Parliament and of the Council (*), the requirements set out in Chapter III, Section 2, of that Regulation shall be
taken into account.
(*)
Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down
harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU)
No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797
and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.
eu/eli/reg/2024/1689/oj).’;
(2) in Article 19, the following paragraph is added:
‘4.
When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which
are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III,
Section 2, of that Regulation shall be taken into account.’;
(3) in Article 43, the following paragraph is added:
‘4.
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According to
Regulation (EU) 2024/1689, the following updates are made:
1. In
Article 43, a new paragraph is added stating that when creating implementing acts related to
Artificial Intelligence systems classified as
safety components, the requirements in
Chapter III, Section 2 of
Regulation (EU) 2024/1689 must be considered.
2. In
Article 47, a new paragraph is added that requires the same consideration for delegated acts concerning
Artificial Intelligence systems that are
safety components.
3. In
Article 57, a new subparagraph is added emphasizing that the requirements in
Chapter III, Section 2 of
Regulation (EU) 2024/1689 must be taken into account when adopting implementing acts for these
AI systems.
4. In
Article 58, a new paragraph is added, reiterating that the requirements in
Chapter III, Section 2 of
Regulation (EU) 2024/1689 should be considered when adopting delegated acts for
AI systems that are
safety components.
(EU) 2024/1689, the requirements set out in Chapter III,
Section 2, of that Regulation shall be taken into account.’;
(3) in Article 43, the following paragraph is added:
‘4.
When adopting implementing acts pursuant to paragraph 1 concerning Artificial Intelligence systems which are
safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III,
Section 2, of that Regulation shall be taken into account.’;
(4) in Article 47, the following paragraph is added:
‘3.
When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which
are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III,
Section 2, of that Regulation shall be taken into account.’;
(5) in Article 57, the following subparagraph is added:
‘When adopting those implementing acts concerning Artificial Intelligence systems which are safety components within
the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall
be taken into account.’;
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(6) in Article 58, the following paragraph is added:
‘3.
When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which
are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III,
Section 2, of that Regulation shall be taken into account.’.
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and 2 concerning Artificial Intelligence systems which
are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III,
Section 2, of that Regulation shall be taken into account.’.
Article 109
Amendment to Regulation (EU) 2019/2144
In Article 11 of Regulation (EU) 2019/2144, the following paragraph is added:
‘3.
When adopting the implementing acts pursuant to paragraph 2, concerning artificial intelligence systems which are
safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council (*),
the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.
(*)
Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised
rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013,
(EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU)
2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/
2024/1689/oj).’.
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The
Artificial Intelligence Act (
OJ L,
2024/1689, 12.7.2024) introduces new rules for artificial intelligence in the EU. Article 110 amends
Directive (EU) 2020/1828 by adding a new point that references
Regulation (EU) 2024/1689, which was established on June 13, 2024. This
regulation sets harmonized rules for
AI and modifies several existing regulations and directives. Article 111 states that
AI systems that are part of large-scale IT systems, as listed in Annex X, and were already on the market before August 2, 2027, must comply with the new regulations by December 31, 2030.
(Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/
2024/1689/oj).’.
Article 110
Amendment to Directive (EU) 2020/1828
In Annex I to Directive (EU) 2020/1828 of the European Parliament and of the Council (58), the following point is added:
‘(68) Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised
rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013,
(EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU)
2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/
2024/1689/oj).’.
Article 111
AI systems already placed on the market or put into service and general-purpose AI models already placed on the
marked
1.
Without prejudice to the application of Article 5 as referred to in Article 113(3), point (a), AI systems which are
components of the large-scale IT systems established by the legal acts listed in Annex X that have been placed on the market
or put into service before 2 August 2027 shall be brought into compliance with this Regulation by 31 December 2030.
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Large-scale IT systems created under the legal acts listed in Annex X that were sold or started operating before August 2, 2027, must comply with this
Regulation by December 31, 2030. The requirements of this
Regulation will be considered when evaluating these IT systems as outlined in the relevant legal acts, especially if those acts are updated or replaced.
Additionally, this
Regulation applies to operators of
high-risk AI systems (not covered in the previous paragraph) that were sold or started operating before August 2, 2026, but only if those systems undergo significant design changes after that date.
Providers and
users of
high-risk AI systems intended for
public authorities must ensure compliance with this
Regulation by August 2, 2030.
Furthermore,
providers of
general-purpose AI models that were sold before August 2, 2025, must comply with this
Regulation by August 2, 2027.
of the large-scale IT systems established by the legal acts listed in Annex X that have been placed on the market
or put into service before 2 August 2027 shall be brought into compliance with this Regulation by 31 December 2030.
The requirements laid down in this Regulation shall be taken into account in the evaluation of each large-scale IT system
established by the legal acts listed in Annex X to be undertaken as provided for in those legal acts and where those legal acts
are replaced or amended.
2.
Without prejudice to the application of Article 5 as referred to in Article 113(3), point (a), this Regulation shall apply
to operators of high-risk AI systems, other than the systems referred to in paragraph 1 of this Article, that have been placed
on the market or put into service before 2 August 2026, only if, as from that date, those systems are subject to significant
changes in their designs. In any case, the providers and deployers of high-risk AI systems intended to be used by public
authorities shall take the necessary steps to comply with the requirements and obligations of this Regulation by 2 August
2030.
3.
Providers of general-purpose AI models that have been placed on the market before 2 August 2025 shall take the
necessary steps in order to comply with the obligations laid down in this Regulation by 2 August 2027.
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(58)
Directive (EU) 2020/1828 of the European Parliament and of the Council of 25 November 2020 on representative actions for the
protection of the collective interests of consumers and repealing Directive 2009/22/EC (OJ L 409, 4.12.2020, p.
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On November 25, 2020, the
Council adopted a
regulation on representative actions to protect consumers' collective interests, replacing
Directive 2009/22/EC (published in
OJ L 409 on December 4, 2020, page 1).
Article 112 outlines the evaluation and review process:
1. The
Commission will review the lists in
Annex III and the
prohibited AI practices in
Article 5 annually after this
regulation takes effect, until the delegation period in
Article 97 ends. The
Commission will report its findings to the
European Parliament and the
Council.
2. By August 2, 2028, and every four years after that, the
Commission will evaluate and report to the
European Parliament and the
Council on:
(a) the need to update existing area headings or add new ones in
Annex III;
(b) changes to the list of
AI systems that require more
transparency as stated in
Article 50;
(c) improvements to the supervision and governance system.
3. By August 2, 2029, and every four years thereafter, the
Commission will submit a report on the evaluation of this
regulation to the
European Parliament and the
Council. This report will assess enforcement structures and whether a
Union agency is needed to address any issues. If necessary, the report will include proposals for amending the
regulation. All reports will be made public.
Council of 25 November 2020 on representative actions for the
protection of the collective interests of consumers and repealing Directive 2009/22/EC (OJ L 409, 4.12.2020, p. 1).
Article 112
Evaluation and review
1.
The Commission shall assess the need for amendment of the list set out in Annex III and of the list of prohibited AI
practices laid down in Article 5, once a year following the entry into force of this Regulation, and until the end of the period
of the delegation of power laid down in Article 97. The Commission shall submit the findings of that assessment to the
European Parliament and the Council.
2.
By 2 August 2028 and every four years thereafter, the Commission shall evaluate and report to the European
Parliament and to the Council on the following:
(a) the need for amendments extending existing area headings or adding new area headings in Annex III;
(b) amendments to the list of AI systems requiring additional transparency measures in Article 50;
(c) amendments enhancing the effectiveness of the supervision and governance system.
3.
By 2 August 2029 and every four years thereafter, the Commission shall submit a report on the evaluation and review
of this Regulation to the European Parliament and to the Council. The report shall include an assessment with regard to the
structure of enforcement and the possible need for a Union agency to resolve any identified shortcomings. On the basis of
the findings, that report shall, where appropriate, be accompanied by a proposal for amendment of this Regulation. The
reports shall be made public.
4.
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A
Union agency may be needed to address any identified issues. Based on the findings, a report will be created, which may include suggestions to amend this
Regulation. These reports will be made public.
The reports must focus on:
(a) the financial, technical, and human resources of
national authorities to effectively carry out their tasks under this
Regulation;
(b) the penalties, especially administrative fines mentioned in
Article 99(1), imposed by
Member States for violations of this
Regulation;
(c) the harmonized standards and
common specifications developed to support this
Regulation;
(d) the number of businesses entering the market after this
Regulation takes effect, particularly how many are small and medium-sized enterprises (
SMEs).
By August 2, 2028, the
Commission will evaluate the
AI Office to determine if it has enough powers and resources to perform its duties effectively. The
Commission will report its findings to the
European Parliament and the
Council.
Additionally, by August 2, 2028, and every four years after that, the
Commission will provide a report on the progress of developing standards for energy-efficient
general-purpose AI models. This report will assess the need for further actions, including mandatory measures, and will be submitted to the
European Parliament and the
Council, and made public.
and the possible need for a Union agency to resolve any identified shortcomings. On the basis of
the findings, that report shall, where appropriate, be accompanied by a proposal for amendment of this Regulation. The
reports shall be made public.
4.
The reports referred to in paragraph 2 shall pay specific attention to the following:
(a) the status of the financial, technical and human resources of the national competent authorities in order to effectively
perform the tasks assigned to them under this Regulation;
(b) the state of penalties, in particular administrative fines as referred to in Article 99(1), applied by Member States for
infringements of this Regulation;
(c) adopted harmonised standards and common specifications developed to support this Regulation;
(d) the number of undertakings that enter the market after the entry into application of this Regulation, and how many of
them are SMEs.
5.
By 2 August 2028, the Commission shall evaluate the functioning of the AI Office, whether the AI Office has been
given sufficient powers and competences to fulfil its tasks, and whether it would be relevant and needed for the proper
implementation and enforcement of this Regulation to upgrade the AI Office and its enforcement competences and to
increase its resources. The Commission shall submit a report on its evaluation to the European Parliament and to the
Council.
6.
By 2 August 2028 and every four years thereafter, the Commission shall submit a report on the review of the progress
on the development of standardisation deliverables on the energy-efficient development of general-purpose AI models, and
asses the need for further measures or actions, including binding measures or actions. The report shall be submitted to the
European Parliament and to the Council, and it shall be made public.
7.
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The report will focus on the energy-efficient development of
general-purpose AI models and will evaluate whether further actions, including mandatory measures, are needed. This report will be submitted to the
European Parliament and the
Council, and it will be made public.
By August 2, 2028, and every three years after that, the
Commission will assess how effective voluntary
codes of conduct are in promoting the requirements for
AI systems that are not classified as high-risk, as well as any additional requirements related to
environmental sustainability.
To support this process, the
Board,
Member States, and
national authorities must provide the
Commission with requested information promptly.
In conducting these evaluations, the
Commission will consider the views and findings from the
Board, the
European Parliament, the
Council, and other relevant organizations.
If necessary, the
Commission will propose amendments to this
Regulation, especially in response to technological advancements, the impact of
AI on
health and safety,
fundamental rights, and the overall progress in the information society.
energy-efficient development of general-purpose AI models, and
asses the need for further measures or actions, including binding measures or actions. The report shall be submitted to the
European Parliament and to the Council, and it shall be made public.
7.
By 2 August 2028 and every three years thereafter, the Commission shall evaluate the impact and effectiveness of
voluntary codes of conduct to foster the application of the requirements set out in Chapter III, Section 2 for AI systems
other than high-risk AI systems and possibly other additional requirements for AI systems other than high-risk AI systems,
including as regards environmental sustainability.
8.
For the purposes of paragraphs 1 to 7, the Board, the Member States and national competent authorities shall provide
the Commission with information upon its request and without undue delay.
9.
In carrying out the evaluations and reviews referred to in paragraphs 1 to 7, the Commission shall take into account
the positions and findings of the Board, of the European Parliament, of the Council, and of other relevant bodies or sources.
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10.
The Commission shall, if necessary, submit appropriate proposals to amend this Regulation, in particular taking into
account developments in technology, the effect of AI systems on health and safety, and on fundamental rights, and in light
of the state of progress in the information society.
11.
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Proposals will be submitted to update this
Regulation, especially considering advancements in technology, the impact of
AI systems on
health and safety, and
fundamental rights, as well as the current state of the information society.
To support the evaluations mentioned in paragraphs 1 to 7 of this Article, the
AI Office will create a fair and inclusive method for assessing risk levels based on the criteria in the relevant Articles. This includes adding new systems to:
(a) the list in
Annex III, which may involve expanding existing categories or adding new ones;
(b) the list of prohibited practices in
Article 5; and
(c) the list of
AI systems that need more
transparency measures as per
Article 50.
Any changes to this
Regulation, as mentioned in paragraph 10, or related delegated or implementing acts, that affect specific
Union harmonization laws listed in Section B of
Annex I, will consider the unique regulations of each sector, along with the current governance, compliance assessment, and enforcement mechanisms and authorities in place.
By August 2, 2031, the
Commission will evaluate how this
Regulation has been enforced and report its findings to the
European Parliament, the
Council, and the
European Economic and Social Committee, reflecting on the initial years of the
Regulation's application. Based on the results, this report may include suggestions for amending the
Regulation regarding enforcement structure and the potential need for a
Union agency to address any identified issues.
This
Regulation will take effect 20 days after its publication in the
Official Journal of the European Union and will be applicable starting August 2, 2026.
, submit appropriate proposals to amend this Regulation, in particular taking into
account developments in technology, the effect of AI systems on health and safety, and on fundamental rights, and in light
of the state of progress in the information society.
11.
To guide the evaluations and reviews referred to in paragraphs 1 to 7 of this Article, the AI Office shall undertake to
develop an objective and participative methodology for the evaluation of risk levels based on the criteria outlined in the
relevant Articles and the inclusion of new systems in:
(a) the list set out in Annex III, including the extension of existing area headings or the addition of new area headings in
that Annex;
(b) the list of prohibited practices set out in Article 5; and
(c) the list of AI systems requiring additional transparency measures pursuant to Article 50.
12.
Any amendment to this Regulation pursuant to paragraph 10, or relevant delegated or implementing acts, which
concerns sectoral Union harmonisation legislation listed in Section B of Annex I shall take into account the regulatory
specificities of each sector, and the existing governance, conformity assessment and enforcement mechanisms and
authorities established therein.
13.
By 2 August 2031, the Commission shall carry out an assessment of the enforcement of this Regulation and shall
report on it to the European Parliament, the Council and the European Economic and Social Committee, taking into
account the first years of application of this Regulation. On the basis of the findings, that report shall, where appropriate, be
accompanied by a proposal for amendment of this Regulation with regard to the structure of enforcement and the need for
a Union agency to resolve any identified shortcomings.
Article 113
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
It shall apply from 2 August 2026.
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Article 113 outlines the entry into force and application of this
Regulation. It will take effect 20 days after its publication in the
Official Journal of the European Union and will be applicable from
2 August 2026. However, specific chapters will have different start dates: Chapters I and II will apply from
2 February 2025; Chapter III Section 4,
Chapter V, Chapter VII, Chapter XII, and
Article 78 will apply from
2 August 2025, except for
Article 101; and
Article 6(1) and its related
obligations will apply from
2 August 2027. This
Regulation is binding and directly applicable in all
Member States. It was finalized in Brussels on
13 June 2024, signed by
R. Metsola, President of the
European Parliament, and
M. Michel, President of the
Council. The document reference is
OJ L, 12.7.2024, with the
ELI link provided.
ANNEX I lists
Union harmonisation legislation based on the
New Legislative Framework, including:
1.
Directive 2006/42/EC on
machinery, amending Directive 95/16/EC;
2.
Directive 2009/48/EC on toy safety.
any identified shortcomings.
Article 113
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
It shall apply from 2 August 2026.
However:
(a) Chapters I and II shall apply from 2 February 2025;
(b) Chapter III Section 4, Chapter V, Chapter VII and Chapter XII and Article 78 shall apply from 2 August 2025, with the
exception of Article 101;
(c) Article 6(1) and the corresponding obligations in this Regulation shall apply from 2 August 2027.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 13 June 2024.
For the European Parliament
The President
R. METSOLA
For the Council
The President
M. MICHEL
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ANNEX I
List of Union harmonisation legislation
Section A. List of Union harmonisation legislation based on the New Legislative Framework
1.
Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending
Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24);
2.
Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ
L 170, 30.6.2009, p. 1);
3.
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The following directives were established by the
European Parliament and Council:
1.
Directive 2009/48/EC on toy safety, dated June 18, 2009 (Official Journal L 170, June 30, 2009, page 1).
2.
Directive 2013/53/EU on recreational craft and personal watercraft, dated November 20, 2013, which repeals Directive 94/25/EC (Official Journal L 354, December 28, 2013, page 90).
3.
Directive 2014/33/EU on the harmonization of laws regarding lifts and
safety components for lifts, dated February 26, 2014 (Official Journal L 96, March 29, 2014, page 251).
4.
Directive 2014/34/EU on the harmonization of laws for equipment and protective systems used in potentially explosive atmospheres, dated February 26, 2014 (Official Journal L 96, March 29, 2014, page 309).
5.
Directive 2014/53/EU on the harmonization of laws for the market availability of radio equipment, dated April 16, 2014, which repeals Directive 1999/5/EC (Official Journal L 153, May 22, 2014, page 62).
6.
Directive 2014/68/EU on the harmonization of laws for the market availability of pressure equipment, dated May 15, 2014 (Official Journal L 189, June 27, 2014, page 164).
2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ
L 170, 30.6.2009, p. 1);
3.
Directive 2013/53/EU of the European Parliament and of the Council of 20 November 2013 on recreational craft
and personal watercraft and repealing Directive 94/25/EC (OJ L 354, 28.12.2013, p. 90);
4.
Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of
the laws of the Member States relating to lifts and safety components for lifts (OJ L 96, 29.3.2014, p. 251);
5.
Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of
the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive
atmospheres (OJ L 96, 29.3.2014, p. 309);
6.
Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the
laws of the Member States relating to the making available on the market of radio equipment and repealing Directive
1999/5/EC (OJ L 153, 22.5.2014, p. 62);
7.
Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the
laws of the Member States relating to the making available on the market of pressure equipment (OJ L 189,
27.6.2014, p. 164);
8.
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On 15 May 2014, a
regulation was established to harmonize the laws of EU
Member States regarding the market availability of pressure equipment (Official Journal L 189, 27 June 2014, page 164). Additionally, several regulations were enacted on 9 March 2016:
Regulation (EU) 2016/424 concerning cableway installations, which replaced Directive 2000/9/EC (Official Journal L 81, 31 March 2016, page 1);
Regulation (EU) 2016/425 on personal protective equipment, which replaced
Council Directive 89/686/EEC (Official Journal L 81, 31 March 2016, page 51); and
Regulation (EU) 2016/426 on appliances that burn gaseous fuels, which replaced Directive 2009/142/EC (Official Journal L 81, 31 March 2016, page 99). Furthermore, on 5 April 2017,
Regulation (EU) 2017/745 was adopted regarding
medical devices, which amended Directive 2001/83/EC,
Regulation (EC) No 178/2002, and
Regulation (EC) No 1223/2009, while repealing
Council Directives 90/385/EEC and 93/42/EEC (Official Journal L 117, 5 May 2017, page 1).
15 May 2014 on the harmonisation of the
laws of the Member States relating to the making available on the market of pressure equipment (OJ L 189,
27.6.2014, p. 164);
8.
Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cableway
installations and repealing Directive 2000/9/EC (OJ L 81, 31.3.2016, p. 1);
9.
Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective
equipment and repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, p. 51);
10.
Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning
gaseous fuels and repealing Directive 2009/142/EC (OJ L 81, 31.3.2016, p. 99);
11.
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices,
amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing
Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1);
12.
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Regulation 1223/2009, which was published in the Official Journal (
OJ L 117, 5.5.2017, p. 1), repeals
Council Directives 90/385/EEC and 93/42/EEC. Additionally,
Regulation (EU) 2017/746, enacted by the
European Parliament and Council on April 5, 2017, addresses
in vitro diagnostic medical devices and replaces
Directive 98/79/EC and
Commission Decision 2010/227/EU (
OJ L 117, 5.5.2017, p. 176).
Other
Union harmonization legislation includes:
1.
Regulation (EC) No 300/2008, which establishes common rules for civil aviation security and repeals
Regulation (EC) No 2320/2002 (
OJ L 97, 9.4.2008, p. 72).
2.
Regulation (EU) No 168/2013, concerning the approval and market surveillance of two- or three-wheel vehicles and quadricycles (
OJ L 60, 2.3.2013, p. 52).
3.
Regulation (EU) No 167/2013, which focuses on the approval and market surveillance of agricultural and forestry vehicles (
OJ L 60, 2.3.2013, p. 1).
1223/2009 and repealing
Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1);
12.
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic
medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017,
p. 176).
Section B. List of other Union harmonisation legislation
13.
Regulation (EC) No 300/2008 of the European Parliament and of the Council of 11 March 2008 on common rules
in the field of civil aviation security and repealing Regulation (EC) No 2320/2002 (OJ L 97, 9.4.2008, p. 72);
14.
Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval
and market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52);
15.
Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval
and market surveillance of agricultural and forestry vehicles (OJ L 60, 2.3.2013, p. 1);
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16.
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In 2014, the
European Parliament and Council issued
Directive 2014/90/EU on marine equipment, which replaced
Council Directive 96/98/EC. In 2016, they introduced
Directive (EU) 2016/797 regarding the interoperability of the rail system in the EU. Then, in 2018,
Regulation (EU) 2018/858 was enacted to oversee the approval and market surveillance of motor vehicles, trailers, and related components, updating previous regulations and replacing Directive 2007/46/EC. Finally, on November 27, 2019,
Regulation (EU) 2019/2144 was adopted, setting type-approval requirements for motor vehicles and trailers, focusing on safety for vehicle occupants and vulnerable road
users, while amending
Regulation (EU) 2018/858 and repealing several earlier regulations.
.2013, p. 1);
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16.
Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and
repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146);
17.
Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of
the rail system within the European Union (OJ L 138, 26.5.2016, p. 44);
18.
Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and
market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units
intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive
2007/46/EC (OJ L 151, 14.6.2018, p. 1);
19.
Regulation (EU) 2019/2144 of the European Parliament and of the Council of 27 November 2019 on type-approval
requirements for motor vehicles and their trailers, and systems, components and separate technical units intended
for such vehicles, as regards their general safety and the protection of vehicle occupants and vulnerable road users,
amending Regulation (EU) 2018/858 of the European Parliament and of the Council and repealing Regulations (EC)
No 78/2009, (EC) No 79/2009 and (EC) No 661
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This document updates
Regulation (EU) 2018/858 from the
European Parliament and Council, and it cancels several previous regulations: (EC) No 78/2009, (EC) No 79/2009, (EC) No 661/2009, and
Commission Regulations (EC) No 631/2009, (EU) No 406/2010, (EU) No 672/2010, (EU) No 1003/2010, (EU) No 1005/2010, (EU) No 1008/2010, (EU) No 1009/2010, (EU) No 19/2011, (EU) No 109/2011, (EU) No 458/2011, (EU) No 65/2012, (EU) No 130/2012, (EU) No 347/2012, (EU) No 351/2012, (EU) No 1230/2012, and (EU) 2015/166. Additionally, it addresses
Regulation (EU) 2018/1139, which was established on July 4, 2018, regarding common rules in civil aviation and the creation of the
European Union Aviation Safety Agency. This
regulation also amends Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014, and Directives 2014/30/EU and 2014/53/EU, while repealing Regulations (EC) No 552/2004 and (EC) No 216/2008.
amending Regulation (EU) 2018/858 of the European Parliament and of the Council and repealing Regulations (EC)
No 78/2009, (EC) No 79/2009 and (EC) No 661/2009 of the European Parliament and of the Council and
Commission Regulations (EC) No 631/2009, (EU) No 406/2010, (EU) No 672/2010, (EU) No 1003/2010,
(EU) No 1005/2010, (EU) No 1008/2010, (EU) No 1009/2010, (EU) No 19/2011, (EU) No 109/2011, (EU)
No 458/2011, (EU) No 65/2012, (EU) No 130/2012, (EU) No 347/2012, (EU) No 351/2012, (EU) No 1230/2012
and (EU) 2015/166 (OJ L 325, 16.12.2019, p. 1);
20.
Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the
field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC)
No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and
2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC)
No 216/2008 of the European Parliament and
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The regulations 2014/30/EU and 2014/53/EU from the
European Parliament and Council replace previous regulations (EC) No 552/2004, (EC) No 216/2008, and
Council Regulation (EEC) No 3922/91. These regulations specifically address the design, production, and marketing of unmanned aircraft, including their engines, propellers, parts, and remote control equipment. This information is published in the Official Journal (
OJ L 212, 22.8.2018, p. 1).
ANNEX II lists the criminal offenses mentioned in
Article 5(1), first subparagraph, point (h)(iii), which include:
- Terrorism
- Human trafficking
- Sexual exploitation of children and child pornography
- Illegal drug trafficking
- Illegal trafficking of weapons, munitions, or explosives
- Murder and serious bodily harm
- Illegal trade in human organs or tissues
- Illegal trafficking of nuclear or radioactive materials
- Kidnapping or hostage-taking
- Crimes under the jurisdiction of the International Criminal Court
- Unlawful seizure of aircraft or ships
- Rape
- Environmental crimes
- Organized or armed robbery
- Sabotage
- Participation in a criminal organization involved in any of the above offenses.
/30/EU and
2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC)
No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212,
22.8.2018, p. 1), in so far as the design, production and placing on the market of aircrafts referred to in Article 2(1),
points (a) and (b) thereof, where it concerns unmanned aircraft and their engines, propellers, parts and equipment to
control them remotely, are concerned.
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ANNEX II
List of criminal offences referred to in Article 5(1), first subparagraph, point (h)(iii)
Criminal offences referred to in Article 5(1), first subparagraph, point (h)(iii):
— terrorism,
— trafficking in human beings,
— sexual exploitation of children, and child pornography,
— illicit trafficking in narcotic drugs or psychotropic substances,
— illicit trafficking in weapons, munitions or explosives,
— murder, grievous bodily injury,
— illicit trade in human organs or tissue,
— illicit trafficking in nuclear or radioactive materials,
— kidnapping, illegal restraint or hostage-taking,
— crimes within the jurisdiction of the International Criminal Court,
— unlawful seizure of aircraft or ships,
— rape,
— environmental crime,
— organised or armed robbery,
— sabotage,
— participation in a criminal organisation involved in one or more of the offences listed above.
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The following actions are considered serious crimes: seizure of aircraft or ships, rape, environmental crime, organized or armed robbery, sabotage, and involvement in a criminal organization related to any of these offenses.
According to
Article 6(2),
high-risk AI systems include those in the following categories:
1.
Biometrics (where allowed by law):
a.
Remote biometric identification systems (excluding those used solely for verifying a person's identity).
b.
AI systems for biometric categorization based on sensitive attributes.
c.
AI systems for emotion recognition.
2.
Critical infrastructure:
AI systems used for safety in managing
critical digital infrastructure, road traffic, or supplying water, gas, heating, or electricity.
3.
Education and vocational training:
a.
AI systems for determining access to educational institutions.
b.
AI systems for evaluating learning outcomes and guiding the learning process.
c.
AI systems for assessing the appropriate education level for individuals in educational institutions.
seizure of aircraft or ships,
— rape,
— environmental crime,
— organised or armed robbery,
— sabotage,
— participation in a criminal organisation involved in one or more of the offences listed above.
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ANNEX III
High-risk AI systems referred to in Article 6(2)
High-risk AI systems pursuant to Article 6(2) are the AI systems listed in any of the following areas:
1.
Biometrics, in so far as their use is permitted under relevant Union or national law:
(a) remote biometric identification systems.
This shall not include AI systems intended to be used for biometric verification the sole purpose of which is to
confirm that a specific natural person is the person he or she claims to be;
(b) AI systems intended to be used for biometric categorisation, according to sensitive or protected attributes or
characteristics based on the inference of those attributes or characteristics;
(c) AI systems intended to be used for emotion recognition.
2.
Critical infrastructure: AI systems intended to be used as safety components in the management and operation of
critical digital infrastructure, road traffic, or in the supply of water, gas, heating or electricity.
3.
Education and vocational training:
(a) AI systems intended to be used to determine access or admission or to assign natural persons to educational and
vocational training institutions at all levels;
(b) AI systems intended to be used to evaluate learning outcomes, including when those outcomes are used to steer
the learning process of natural persons in educational and vocational training institutions at all levels;
(c) AI systems intended to be used for the purpose of assessing the appropriate level of education that an individual
will receive or will be able to access, in the context of or within educational and vocational training institutions
at all levels;
(d) AI systems intended
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AI systems are designed for various purposes in education, employment, and access to essential services. In education, they assess the appropriate level of education for individuals and monitor student behavior during tests. In employment, these systems help with recruiting by placing job ads, analyzing applications, and evaluating candidates. They also make decisions about work relationships, such as promotions or terminations, and monitor employee performance. For essential services,
AI systems evaluate eligibility for
public assistance benefits, including healthcare, and determine creditworthiness, except for fraud detection. They are also used for
risk assessment and pricing in life and health insurance.
AI systems intended to be used for the purpose of assessing the appropriate level of education that an individual
will receive or will be able to access, in the context of or within educational and vocational training institutions
at all levels;
(d) AI systems intended to be used for monitoring and detecting prohibited behaviour of students during tests in the
context of or within educational and vocational training institutions at all levels.
4.
Employment, workers’ management and access to self-employment:
(a) AI systems intended to be used for the recruitment or selection of natural persons, in particular to place targeted
job advertisements, to analyse and filter job applications, and to evaluate candidates;
(b) AI systems intended to be used to make decisions affecting terms of work-related relationships, the promotion or
termination of work-related contractual relationships, to allocate tasks based on individual behaviour or personal
traits or characteristics or to monitor and evaluate the performance and behaviour of persons in such
relationships.
5.
Access to and enjoyment of essential private services and essential public services and benefits:
(a) AI systems intended to be used by public authorities or on behalf of public authorities to evaluate the eligibility
of natural persons for essential public assistance benefits and services, including healthcare services, as well as to
grant, reduce, revoke, or reclaim such benefits and services;
(b) AI systems intended to be used to evaluate the creditworthiness of natural persons or establish their credit score,
with the exception of AI systems used for the purpose of detecting financial fraud;
(c) AI systems intended to be used for risk assessment and pricing in relation to natural persons in the case of life
and health insurance;
OJ L, 12.7.
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AI systems are excluded from certain regulations if they are used for: (a) detecting financial fraud; (b) assessing risk and pricing for life and health insurance for individuals; (c) evaluating and prioritizing emergency calls and dispatching emergency services like police, firefighters, and medical aid, including patient triage systems. Additionally,
law enforcement can use
AI systems under relevant laws for: (a) assessing the risk of someone becoming a victim of crime; (b) using
polygraphs or similar tools; (c) evaluating the reliability of evidence during criminal investigations or prosecutions; (d) assessing the risk of an individual committing or re-committing a crime, based on more than just profiling.
exception of AI systems used for the purpose of detecting financial fraud;
(c) AI systems intended to be used for risk assessment and pricing in relation to natural persons in the case of life
and health insurance;
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(d) AI systems intended to evaluate and classify emergency calls by natural persons or to be used to dispatch, or to
establish priority in the dispatching of, emergency first response services, including by police, firefighters and
medical aid, as well as of emergency healthcare patient triage systems.
6.
Law enforcement, in so far as their use is permitted under relevant Union or national law:
(a) AI systems intended to be used by or on behalf of law enforcement authorities, or by Union institutions, bodies,
offices or agencies in support of law enforcement authorities or on their behalf to assess the risk of a natural
person becoming the victim of criminal offences;
(b) AI systems intended to be used by or on behalf of law enforcement authorities or by Union institutions, bodies,
offices or agencies in support of law enforcement authorities as polygraphs or similar tools;
(c) AI systems intended to be used by or on behalf of law enforcement authorities, or by Union institutions, bodies,
offices or agencies, in support of law enforcement authorities to evaluate the reliability of evidence in the course
of the investigation or prosecution of criminal offences;
(d) AI systems intended to be used by law enforcement authorities or on their behalf or by Union institutions,
bodies, offices or agencies in support of law enforcement authorities for assessing the risk of a natural person
offending or re-offending not solely on the basis of the profiling of natural persons as referred to in Article 3(4)
of Directive (EU) 2016/680, or to assess personality traits and characteristics or past
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AI systems cannot be used to determine if a person is likely to commit a crime based solely on their profile, personality traits, or past criminal behavior. These systems are intended for use by
law enforcement or EU institutions to help in detecting, investigating, or prosecuting crimes, as outlined in
Article 3(4) of
Directive (EU) 2016/680.
In the context of
migration,
asylum, and border control,
AI systems can be used by
public authorities or EU institutions under relevant laws for the following purposes:
(a) As
polygraphs or similar tools.
(b) To assess risks, including security, irregular
migration, or health risks, for individuals entering or already in a
Member State.
(c) To assist in reviewing applications for
asylum, visas, or residence permits, including evaluating the reliability of evidence provided by applicants.
(d) To help detect, recognize, or identify individuals in
migration,
asylum, or border control processes.
person
offending or re-offending not solely on the basis of the profiling of natural persons as referred to in Article 3(4)
of Directive (EU) 2016/680, or to assess personality traits and characteristics or past criminal behaviour of
natural persons or groups;
(e) AI systems intended to be used by or on behalf of law enforcement authorities or by Union institutions, bodies,
offices or agencies in support of law enforcement authorities for the profiling of natural persons as referred to in
Article 3(4) of Directive (EU) 2016/680 in the course of the detection, investigation or prosecution of criminal
offences.
7.
Migration, asylum and border control management, in so far as their use is permitted under relevant Union or
national law:
(a) AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies,
offices or agencies as polygraphs or similar tools;
(b) AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies,
offices or agencies to assess a risk, including a security risk, a risk of irregular migration, or a health risk, posed
by a natural person who intends to enter or who has entered into the territory of a Member State;
(c) AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies,
offices or agencies to assist competent public authorities for the examination of applications for asylum, visa or
residence permits and for associated complaints with regard to the eligibility of the natural persons applying for
a status, including related assessments of the reliability of evidence;
(d) AI systems intended to be used by or on behalf of competent public authorities, or by Union institutions, bodies,
offices or agencies, in the context of migration, asylum or border control management, for the purpose of
detecting, recognising or identifying natural persons,
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AI systems can be used by
public authorities or EU institutions for managing
migration,
asylum, or border control. Their purpose is to detect, recognize, or identify individuals, but they do not include checking travel documents.
For the administration of justice and democratic processes:
(a)
AI systems may assist judicial authorities in researching facts and laws, and applying them to specific cases, or in alternative dispute resolution.
(b)
AI systems should not be used to influence election outcomes or voter behavior directly. However, tools that help organize or manage political campaigns without directly exposing individuals to
AI outputs are excluded from this restriction.
ANNEX IV outlines the
technical documentation required in
Article 11(1), which must include specific information relevant to the
AI system.
used by or on behalf of competent public authorities, or by Union institutions, bodies,
offices or agencies, in the context of migration, asylum or border control management, for the purpose of
detecting, recognising or identifying natural persons, with the exception of the verification of travel documents.
8.
Administration of justice and democratic processes:
(a) AI systems intended to be used by a judicial authority or on their behalf to assist a judicial authority in
researching and interpreting facts and the law and in applying the law to a concrete set of facts, or to be used in
a similar way in alternative dispute resolution;
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(b) AI systems intended to be used for influencing the outcome of an election or referendum or the voting
behaviour of natural persons in the exercise of their vote in elections or referenda. This does not include AI
systems to the output of which natural persons are not directly exposed, such as tools used to organise, optimise
or structure political campaigns from an administrative or logistical point of view.
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ANNEX IV
Technical documentation referred to in Article 11(1)
The technical documentation referred to in Article 11(1) shall contain at least the following information, as applicable to
the relevant AI system:
1.
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ANNEX IV
Technical Documentation Required by
Article 11(1)
The
technical documentation mentioned in
Article 11(1) must include at least the following information relevant to the
AI system:
1. A general description of the
AI system, which should cover:
(a) Its intended purpose, the
provider's name, and the system version in relation to previous versions;
(b) How the
AI system interacts with
hardware or software, including other
AI systems, if applicable;
(c) Versions of relevant software or firmware and any requirements for updates;
(d) The different forms in which the
AI system is available, such as
software packages, downloads, or APIs;
(e) The
hardware specifications on which the
AI system is designed to operate;
(f) If the
AI system is part of other products, include photos or illustrations showing the external features, markings, and internal layout of those products;
(g) A basic description of the
user interface for the
deployer;
(h) Instructions for the
deployer and a basic description of the
user interface, if applicable.
2. A detailed description of the
AI system's components and its development process, including:
(a) The methods and steps taken to develop the
AI system, including the use of pre-trained systems or third-party tools, and how these were integrated or modified by the
provider;
(b) The design specifications of the system, including the overall logic of the
AI system and algorithms, key design choices, and the rationale behind them, especially regarding the intended
users or groups.
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ANNEX IV
Technical documentation referred to in Article 11(1)
The technical documentation referred to in Article 11(1) shall contain at least the following information, as applicable to
the relevant AI system:
1.
A general description of the AI system including:
(a) its intended purpose, the name of the provider and the version of the system reflecting its relation to previous
versions;
(b) how the AI system interacts with, or can be used to interact with, hardware or software, including with other AI
systems, that are not part of the AI system itself, where applicable;
(c) the versions of relevant software or firmware, and any requirements related to version updates;
(d) the description of all the forms in which the AI system is placed on the market or put into service, such as
software packages embedded into hardware, downloads, or APIs;
(e) the description of the hardware on which the AI system is intended to run;
(f) where the AI system is a component of products, photographs or illustrations showing external features, the
marking and internal layout of those products;
(g) a basic description of the user-interface provided to the deployer;
(h) instructions for use for the deployer, and a basic description of the user-interface provided to the deployer, where
applicable;
2.
A detailed description of the elements of the AI system and of the process for its development, including:
(a) the methods and steps performed for the development of the AI system, including, where relevant, recourse to
pre-trained systems or tools provided by third parties and how those were used, integrated or modified by the
provider;
(b) the design specifications of the system, namely the general logic of the AI system and of the algorithms; the key
design choices including the rationale and assumptions made, including with regard to persons or groups of
persons in respect of who, the system is intended to be used; the main classification choices
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This document outlines the following key aspects of the
AI system:
1. **General Logic and Design Choices**: It explains the overall logic of the
AI system and the algorithms used, including the main design decisions, assumptions made about the intended
users, classification choices, optimization goals, and the significance of various
parameters. It also describes the expected output and its quality, as well as any trade-offs made in
technical solutions to meet the requirements in
Chapter III, Section 2.
2. **
System Architecture**: It details how the software components interact and integrate within the system, along with the
computational resources used for developing, training, testing, and validating the
AI system.
3. **
Data Requirements**: It includes information about the
data needed for the system, such as datasheets that describe the training methods and datasets used. This section covers the characteristics of the datasets, their origin, how they were selected, labeling procedures for supervised learning, and
data cleaning methods like outlier detection.
4. **
Human Oversight Measures**: It assesses the necessary
human oversight measures as per
Article 14, including technical measures to help
users interpret the
AI outputs, in line with
Article 13(3), point (d).
5. **Pre-determined Changes**: If applicable, it provides a detailed description of any planned changes to the
AI system and its performance, along with information on
technical solutions to ensure ongoing compliance with the requirements in
Chapter III, Section 2.
6. **
Validation and Testing Procedures**: It outlines the validation and testing processes used, including details about the validation and testing
data and their characteristics, as well as the metrics employed to measure
accuracy,
robustness, and compliance with relevant requirements in
Chapter III, Section 2.
general logic of the AI system and of the algorithms; the key
design choices including the rationale and assumptions made, including with regard to persons or groups of
persons in respect of who, the system is intended to be used; the main classification choices; what the system is
designed to optimise for, and the relevance of the different parameters; the description of the expected output
and output quality of the system; the decisions about any possible trade-off made regarding the technical
solutions adopted to comply with the requirements set out in Chapter III, Section 2;
(c) the description of the system architecture explaining how software components build on or feed into each other
and integrate into the overall processing; the computational resources used to develop, train, test and validate the
AI system;
(d) where relevant, the data requirements in terms of datasheets describing the training methodologies and
techniques and the training data sets used, including a general description of these data sets, information about
their provenance, scope and main characteristics; how the data was obtained and selected; labelling procedures
(e.g. for supervised learning), data cleaning methodologies (e.g. outliers detection);
(e) assessment of the human oversight measures needed in accordance with Article 14, including an assessment of
the technical measures needed to facilitate the interpretation of the outputs of AI systems by the deployers, in
accordance with Article 13(3), point (d);
(f) where applicable, a detailed description of pre-determined changes to the AI system and its performance,
together with all the relevant information related to the technical solutions adopted to ensure continuous
compliance of the AI system with the relevant requirements set out in Chapter III, Section 2;
(g) the validation and testing procedures used, including information about the validation and testing data used and
their main characteristics; metrics used to measure accuracy, robustness and compliance with other relevant
requirements set out in Chapter III, Section 2
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2; (g) Information about the
validation and testing procedures, including details on the
data used for validation and testing, their main characteristics, and the metrics for measuring
accuracy,
robustness, and compliance with requirements in
Chapter III, Section 2. This includes assessing potential discriminatory impacts, along with test
logs and reports that are dated and signed by responsible individuals, especially regarding any pre-determined changes mentioned in point (f); (h)
Cybersecurity measures implemented; 3. Detailed information on monitoring, functioning, and control of the
AI system, focusing on its performance capabilities and limitations, including
accuracy levels for specific individuals or groups it is designed for, and the overall expected
accuracy for its intended use. This also covers potential unintended consequences and risks to health, safety,
fundamental rights, and
discrimination related to the
AI system's purpose, as well as necessary
human oversight measures as per
Article 14, including technical measures to help
users interpret
AI outputs and specifications for input
data where applicable; 4. An evaluation of how suitable the
performance metrics are for the specific
AI system; 5. A comprehensive description of the
risk management system as outlined in
Article 9; 6. An account of significant changes made by the
provider to the system throughout its lifecycle;
2;
(g) the validation and testing procedures used, including information about the validation and testing data used and
their main characteristics; metrics used to measure accuracy, robustness and compliance with other relevant
requirements set out in Chapter III, Section 2, as well as potentially discriminatory impacts; test logs and all test
reports dated and signed by the responsible persons, including with regard to pre-determined changes as referred
to under point (f);
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(h) cybersecurity measures put in place;
3.
Detailed information about the monitoring, functioning and control of the AI system, in particular with regard to:
its capabilities and limitations in performance, including the degrees of accuracy for specific persons or groups of
persons on which the system is intended to be used and the overall expected level of accuracy in relation to its
intended purpose; the foreseeable unintended outcomes and sources of risks to health and safety, fundamental rights
and discrimination in view of the intended purpose of the AI system; the human oversight measures needed in
accordance with Article 14, including the technical measures put in place to facilitate the interpretation of the
outputs of AI systems by the deployers; specifications on input data, as appropriate;
4.
A description of the appropriateness of the performance metrics for the specific AI system;
5.
A detailed description of the risk management system in accordance with Article 9;
6.
A description of relevant changes made by the provider to the system through its lifecycle;
7.
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appropriateness of the performance metrics for the specific AI system;
5.
A detailed description of the risk management system in accordance with Article 9;
6.
A description of relevant changes made by the provider to the system through its lifecycle;
7.
A list of the harmonised standards applied in full or in part the references of which have been published in the
Official Journal of the European Union; where no such harmonised standards have been applied, a detailed description
of the solutions adopted to meet the requirements set out in Chapter III, Section 2, including a list of other relevant
standards and technical specifications applied;
8.
A copy of the EU declaration of conformity referred to in Article 47;
9.
A detailed description of the system in place to evaluate the AI system performance in the post-market phase in
accordance with Article 72, including the post-market monitoring plan referred to in Article 72(3).
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ANNEX V
EU declaration of conformity
The EU declaration of conformity referred to in Article 47, shall contain all of the following information:
1.
AI system name and type and any additional unambiguous reference allowing the identification and traceability of
the AI system;
2.
The name and address of the provider or, where applicable, of their authorised representative;
3.
A statement that the EU declaration of conformity referred to in Article 47 is issued under the sole responsibility of
the provider;
4.
A statement that the AI system is in conformity with this Regulation and, if applicable, with any other relevant
Union law that provides for the issuing of the EU declaration of conformity referred to in Article 47;
5.
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The
provider must include the following in their declaration: 1. A statement confirming that the
AI system meets this
Regulation and any other relevant EU laws that require an
EU declaration of conformity as mentioned in
Article 47. 2. If the
AI system processes
personal data, a statement confirming compliance with
Regulations (EU) 2016/679 and (EU) 2018/1725, as well as
Directive (EU) 2016/680. 3. References to any relevant harmonized standards or
common specifications used to declare conformity. 4. If applicable, the name and identification number of the
notified body, a description of the
conformity assessment procedure conducted, and details of the issued certificate. 5. The place and date of the declaration's issue, the name and role of the person who signed it, who they represent, and their signature.
ANNEX VI outlines the
conformity assessment procedure based on internal control: 1. This procedure is based on points 2, 3, and 4. 2. The
provider checks that their
quality management system complies with
Article 17. 3. The
provider reviews the
technical documentation to ensure the
AI system meets the essential requirements in
Chapter III, Section 2. 4. The
provider verifies that the design and development process of the
AI system and its post-market monitoring, as mentioned in
Article 72, align with the
technical documentation.
the provider;
4.
A statement that the AI system is in conformity with this Regulation and, if applicable, with any other relevant
Union law that provides for the issuing of the EU declaration of conformity referred to in Article 47;
5.
Where an AI system involves the processing of personal data, a statement that that AI system complies with
Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680;
6.
References to any relevant harmonised standards used or any other common specification in relation to which
conformity is declared;
7.
Where applicable, the name and identification number of the notified body, a description of the conformity
assessment procedure performed, and identification of the certificate issued;
8.
The place and date of issue of the declaration, the name and function of the person who signed it, as well as an
indication for, or on behalf of whom, that person signed, a signature.
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ANNEX VI
Conformity assessment procedure based on internal control
1.
The conformity assessment procedure based on internal control is the conformity assessment procedure based on
points 2, 3 and 4.
2.
The provider verifies that the established quality management system is in compliance with the requirements of
Article 17.
3.
The provider examines the information contained in the technical documentation in order to assess the compliance
of the AI system with the relevant essential requirements set out in Chapter III, Section 2.
4.
The provider also verifies that the design and development process of the AI system and its post-market monitoring
as referred to in Article 72 is consistent with the technical documentation.
OJ L, 12.7.
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, Section 2.
4.
The provider also verifies that the design and development process of the AI system and its post-market monitoring
as referred to in Article 72 is consistent with the technical documentation.
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ANNEX VII
Conformity based on an assessment of the quality management system and an assessment of the
technical documentation
1.
Introduction
Conformity based on an assessment of the quality management system and an assessment of the technical
documentation is the conformity assessment procedure based on points 2 to 5.
2.
Overview
The approved quality management system for the design, development and testing of AI systems pursuant to
Article 17 shall be examined in accordance with point 3 and shall be subject to surveillance as specified in point 5.
The technical documentation of the AI system shall be examined in accordance with point 4.
3.
Quality management system
3.1.
The application of the provider shall include:
(a) the name and address of the provider and, if the application is lodged by an authorised representative, also their
name and address;
(b) the list of AI systems covered under the same quality management system;
(c) the technical documentation for each AI system covered under the same quality management system;
(d) the documentation concerning the quality management system which shall cover all the aspects listed under
Article 17;
(e) a description of the procedures in place to ensure that the quality management system remains adequate and
effective;
(f) a written declaration that the same application has not been lodged with any other notified body.
3.2.
The quality management system shall be assessed by the notified body, which shall determine whether it satisfies the
requirements referred to in Article 17.
The decision shall be notified to the provider or its authorised representative.
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any other notified body.
3.2.
The quality management system shall be assessed by the notified body, which shall determine whether it satisfies the
requirements referred to in Article 17.
The decision shall be notified to the provider or its authorised representative.
The notification shall contain the conclusions of the assessment of the quality management system and the reasoned
assessment decision.
3.3.
The quality management system as approved shall continue to be implemented and maintained by the provider so
that it remains adequate and efficient.
3.4.
Any intended change to the approved quality management system or the list of AI systems covered by the latter shall
be brought to the attention of the notified body by the provider.
The proposed changes shall be examined by the notified body, which shall decide whether the modified quality
management system continues to satisfy the requirements referred to in point 3.2 or whether a reassessment is
necessary.
The notified body shall notify the provider of its decision. The notification shall contain the conclusions of the
examination of the changes and the reasoned assessment decision.
4.
Control of the technical documentation.
4.1.
In addition to the application referred to in point 3, an application with a notified body of their choice shall be
lodged by the provider for the assessment of the technical documentation relating to the AI system which the
provider intends to place on the market or put into service and which is covered by the quality management system
referred to under point 3.
4.2.
The application shall include:
(a) the name and address of the provider;
(b) a written declaration that the same application has not been lodged with any other notified body;
(c) the technical documentation referred to in Annex IV.
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4.3.
The technical documentation shall be examined by the notified body.
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On July 12, 2024, the
technical documentation for
AI systems must be reviewed by a
notified body. This body will have full access to the training, validation, and
testing data sets used, as needed, including remote access through APIs or other technical tools, while ensuring security. If the
notified body needs more information or tests to properly assess the
AI system's compliance with the requirements in
Chapter III, Section 2, it can request additional evidence or conduct its own tests if the initial tests are unsatisfactory. If necessary, after exhausting other verification methods, the
notified body can also access the
AI system's training and trained models, including relevant
parameters, while respecting intellectual property and trade secret laws. The
notified body will inform the
provider or their representative of its decision, including the assessment conclusions. If the
AI system meets the requirements, the
notified body will issue a
Union technical documentation assessment certificate.
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4.3.
The technical documentation shall be examined by the notified body. Where relevant, and limited to what is
necessary to fulfil its tasks, the notified body shall be granted full access to the training, validation, and testing data
sets used, including, where appropriate and subject to security safeguards, through API or other relevant technical
means and tools enabling remote access.
4.4.
In examining the technical documentation, the notified body may require that the provider supply further evidence
or carry out further tests so as to enable a proper assessment of the conformity of the AI system with the
requirements set out in Chapter III, Section 2. Where the notified body is not satisfied with the tests carried out by
the provider, the notified body shall itself directly carry out adequate tests, as appropriate.
4.5.
Where necessary to assess the conformity of the high-risk AI system with the requirements set out in Chapter III,
Section 2, after all other reasonable means to verify conformity have been exhausted and have proven to be
insufficient, and upon a reasoned request, the notified body shall also be granted access to the training and trained
models of the AI system, including its relevant parameters. Such access shall be subject to existing Union law on the
protection of intellectual property and trade secrets.
4.6.
The decision of the notified body shall be notified to the provider or its authorised representative. The notification
shall contain the conclusions of the assessment of the technical documentation and the reasoned assessment
decision.
Where the AI system is in conformity with the requirements set out in Chapter III, Section 2, the notified body shall
issue a Union technical documentation assessment certificate.
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This document summarizes the findings from the assessment of the
technical documentation and the decision made based on that assessment. If the
AI system meets the requirements outlined in
Chapter III, Section 2, the
notified body will issue a
Union technical documentation assessment certificate. This certificate will include the
provider's name and address, the assessment conclusions, any conditions for its validity, and details needed to identify the
AI system.
The certificate and its attachments will provide all necessary information to evaluate the
AI system's compliance and to monitor it during use, if applicable.
If the
AI system does not meet the requirements in
Chapter III, Section 2, the
notified body will deny the issuance of the certificate and will inform the applicant with detailed reasons for the refusal.
If the
AI system fails to meet the
data quality requirements for training, it must be retrained before applying for a new
conformity assessment. In this case, the
notified body's refusal will include specific reasons related to the quality of the
training data.
Any changes to the
AI system that might affect its compliance or intended purpose must be assessed by the
notified body that issued the certificate. The
provider must notify this body of any planned changes or if they become aware of any changes that have occurred.
contain the conclusions of the assessment of the technical documentation and the reasoned assessment
decision.
Where the AI system is in conformity with the requirements set out in Chapter III, Section 2, the notified body shall
issue a Union technical documentation assessment certificate. The certificate shall indicate the name and address of
the provider, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for the
identification of the AI system.
The certificate and its annexes shall contain all relevant information to allow the conformity of the AI system to be
evaluated, and to allow for control of the AI system while in use, where applicable.
Where the AI system is not in conformity with the requirements set out in Chapter III, Section 2, the notified body
shall refuse to issue a Union technical documentation assessment certificate and shall inform the applicant
accordingly, giving detailed reasons for its refusal.
Where the AI system does not meet the requirement relating to the data used to train it, re-training of the AI system
will be needed prior to the application for a new conformity assessment. In this case, the reasoned assessment
decision of the notified body refusing to issue the Union technical documentation assessment certificate shall
contain specific considerations on the quality data used to train the AI system, in particular on the reasons for
non-compliance.
4.7.
Any change to the AI system that could affect the compliance of the AI system with the requirements or its intended
purpose shall be assessed by the notified body which issued the Union technical documentation assessment
certificate. The provider shall inform such notified body of its intention to introduce any of the abovementioned
changes, or if it otherwise becomes aware of the occurrence of such changes.
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be assessed by the notified body which issued the Union technical documentation assessment
certificate. The provider shall inform such notified body of its intention to introduce any of the abovementioned
changes, or if it otherwise becomes aware of the occurrence of such changes. The intended changes shall be assessed
by the notified body, which shall decide whether those changes require a new conformity assessment in accordance
with Article 43(4) or whether they could be addressed by means of a supplement to the Union technical
documentation assessment certificate. In the latter case, the notified body shall assess the changes, notify the
provider of its decision and, where the changes are approved, issue to the provider a supplement to the Union
technical documentation assessment certificate.
5.
Surveillance of the approved quality management system.
5.1.
The purpose of the surveillance carried out by the notified body referred to in Point 3 is to make sure that the
provider duly complies with the terms and conditions of the approved quality management system.
5.2.
For assessment purposes, the provider shall allow the notified body to access the premises where the design,
development, testing of the AI systems is taking place. The provider shall further share with the notified body all
necessary information.
5.3.
The notified body shall carry out periodic audits to make sure that the provider maintains and applies the quality
management system and shall provide the provider with an audit report. In the context of those audits, the notified
body may carry out additional tests of the AI systems for which a Union technical documentation assessment
certificate was issued.
OJ L, 12.7.
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The
provider must give an
audit report. During these audits, the
notified body can perform extra tests on the
AI systems that have received a
Union technical documentation assessment certificate.
**
ANNEX VIII**
**Information Required for Registering
High-Risk AI Systems (
Article 49)**
**Section A — Information from
Providers of
High-Risk AI Systems (
Article 49(1))**
Providers must submit and keep updated the following information for
high-risk AI systems:
1.
Provider's name, address, and contact details;
2. If someone else submits information for the
provider, their name, address, and contact details;
3. Name, address, and contact details of the authorized representative, if applicable;
4. Trade name of the
AI system and any other clear reference for identification and traceability;
5. Description of the
AI system's intended purpose and its components and functions;
6. A brief description of the
data used by the system and how it operates;
7. Status of the
AI system (whether it is on the market, in service, no longer available, or recalled);
8. Type, number, and expiry date of the certificate from the
notified body, along with the name or ID number of that body, if applicable;
9. A scanned copy of the certificate mentioned in point 8, if applicable.
shall provide the provider with an audit report. In the context of those audits, the notified
body may carry out additional tests of the AI systems for which a Union technical documentation assessment
certificate was issued.
OJ L, 12.7.2024
EN
ELI: http://data.europa.eu/eli/reg/2024/1689/oj
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ANNEX VIII
Information to be submitted upon the registration of high-risk AI systems in accordance with
Article 49
Section A — Information to be submitted by providers of high-risk AI systems in accordance with Article 49(1)
The following information shall be provided and thereafter kept up to date with regard to high-risk AI systems to be
registered in accordance with Article 49(1):
1.
The name, address and contact details of the provider;
2.
Where submission of information is carried out by another person on behalf of the provider, the name, address and
contact details of that person;
3.
The name, address and contact details of the authorised representative, where applicable;
4.
The AI system trade name and any additional unambiguous reference allowing the identification and traceability of
the AI system;
5.
A description of the intended purpose of the AI system and of the components and functions supported through
this AI system;
6.
A basic and concise description of the information used by the system (data, inputs) and its operating logic;
7.
The status of the AI system (on the market, or in service; no longer placed on the market/in service, recalled);
8.
The type, number and expiry date of the certificate issued by the notified body and the name or identification
number of that notified body, where applicable;
9.
A scanned copy of the certificate referred to in point 8, where applicable;
10.
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The following information must be provided for
AI systems registered under
Article 49(2):
1. The type, number, and expiry date of the certificate from the
notified body, along with the name or identification number of that body, if applicable.
2. A scanned copy of the certificate mentioned in point 1, if applicable.
3. The
Member States where the
AI system has been marketed, put into service, or made available in the EU.
4. A copy of the
EU declaration of conformity as stated in
Article 47.
5. Electronic
instructions for use, except for
high-risk AI systems related to
law enforcement or
migration,
asylum, and
border control management as listed in
Annex III, points 1, 6, and 7.
6. An optional URL for additional information.
Section B — Information required from
providers of
high-risk AI systems:
1. The
provider's name, address, and contact details.
2. If someone else submits information on behalf of the
provider, their name, address, and contact details.
3. The name, address, and contact details of the authorized representative, if applicable.
4. The trade name of the
AI system and any other clear reference for identification and traceability.
5. A description of the
AI system's intended purpose.
6. The conditions under
Article 6(3) that classify the
AI system as not high-risk.
7. A brief summary explaining why the
AI system is considered not high-risk according to
Article 6(3).
8. The current status of the
AI system (whether it is on the market, in service, no longer available, or recalled).
The type, number and expiry date of the certificate issued by the notified body and the name or identification
number of that notified body, where applicable;
9.
A scanned copy of the certificate referred to in point 8, where applicable;
10.
Any Member States in which the AI system has been placed on the market, put into service or made available in the
Union;
11.
A copy of the EU declaration of conformity referred to in Article 47;
12.
Electronic instructions for use; this information shall not be provided for high-risk AI systems in the areas of law
enforcement or migration, asylum and border control management referred to in Annex III, points 1, 6 and 7;
13.
A URL for additional information (optional).
Section B — Information to be submitted by providers of high-risk AI systems in accordance with Article 49(2)
The following information shall be provided and thereafter kept up to date with regard to AI systems to be registered in
accordance with Article 49(2):
1.
The name, address and contact details of the provider;
2.
Where submission of information is carried out by another person on behalf of the provider, the name, address and
contact details of that person;
3.
The name, address and contact details of the authorised representative, where applicable;
4.
The AI system trade name and any additional unambiguous reference allowing the identification and traceability of
the AI system;
5.
A description of the intended purpose of the AI system;
6.
The condition or conditions under Article 6(3)based on which the AI system is considered to be not-high-risk;
7.
A short summary of the grounds on which the AI system is considered to be not-high-risk in application of the
procedure under Article 6(3);
8.
The status of the AI system (on the market, or in service; no longer placed on the market/in service, recalled);
9.
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is considered to be not-high-risk in application of the
procedure under Article 6(3);
8.
The status of the AI system (on the market, or in service; no longer placed on the market/in service, recalled);
9.
Any Member States in which the AI system has been placed on the market, put into service or made available in the
Union.
EN
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ELI: http://data.europa.eu/eli/reg/2024/1689/oj
Section C — Information to be submitted by deployers of high-risk AI systems in accordance with Article 49(3)
The following information shall be provided and thereafter kept up to date with regard to high-risk AI systems to be
registered in accordance with Article 49(3):
1.
The name, address and contact details of the deployer;
2.
The name, address and contact details of the person submitting information on behalf of the deployer;
3.
The URL of the entry of the AI system in the EU database by its provider;
4.
A summary of the findings of the fundamental rights impact assessment conducted in accordance with Article 27;
5.
A summary of the data protection impact assessment carried out in accordance with Article 35 of Regulation (EU)
2016/679 or Article 27 of Directive (EU) 2016/680 as specified in Article 26(8) of this Regulation, where
applicable.
OJ L, 12.7.
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Regulation (EU) 2016/679 and
Article 27 of Directive (EU) 2016/680, as mentioned in
Article 26(8) of this
Regulation, are applicable. The official journal reference is
OJ L, 12.7.2024, and more details can be found at http://
data.europa.eu/
eli/
reg/2024/1689/oj.
ANNEX IX outlines the information required for registering
high-risk AI systems listed in
Annex III, specifically regarding real-world testing as per
Article 60. The following details must be submitted and kept updated:
1. A unique identification number for the real-world testing.
2. The name and contact information of the
provider and deployers involved in the testing.
3. A brief description of the
AI system, its intended use, and other identifying information.
4. A summary of the main features of the
real-world testing plan.
5. Information about any suspension or termination of the testing.
ANNEX X lists
Union legislative acts related to large-scale IT systems in the area of Freedom, Security, and Justice, including the
Schengen Information System, governed by
Regulation (EU) 2018/1860, which pertains to the use of the
Schengen Information System for returning illegally staying third-country nationals (
OJ L 312, 7.12.2018, p. 1).
Regulation (EU)
2016/679 or Article 27 of Directive (EU) 2016/680 as specified in Article 26(8) of this Regulation, where
applicable.
OJ L, 12.7.2024
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ELI: http://data.europa.eu/eli/reg/2024/1689/oj
137/144
ANNEX IX
Information to be submitted upon the registration of high-risk AI systems listed in Annex III in
relation to testing in real world conditions in accordance with Article 60
The following information shall be provided and thereafter kept up to date with regard to testing in real world conditions to
be registered in accordance with Article 60:
1.
A Union-wide unique single identification number of the testing in real world conditions;
2.
The name and contact details of the provider or prospective provider and of the deployers involved in the testing in
real world conditions;
3.
A brief description of the AI system, its intended purpose, and other information necessary for the identification of
the system;
4.
A summary of the main characteristics of the plan for testing in real world conditions;
5.
Information on the suspension or termination of the testing in real world conditions.
EN
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ELI: http://data.europa.eu/eli/reg/2024/1689/oj
ANNEX X
Union legislative acts on large-scale IT systems in the area of Freedom, Security and Justice
1.
Schengen Information System
(a) Regulation (EU) 2018/1860 of the European Parliament and of the Council of 28 November 2018 on the use of
the Schengen Information System for the return of illegally staying third-country nationals (OJ L 312,
7.12.2018, p. 1).
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On 28 November 2018, the
Council adopted several regulations regarding the
Schengen Information System (SIS):
(a)
Regulation (EU) 2018/1860 focuses on using the SIS to help return third-country nationals who are staying illegally (published in
OJ L 312, 7.12.2018, p. 1).
(b)
Regulation (EU) 2018/1861 outlines the establishment, operation, and use of the SIS for border checks, while also amending the Schengen Agreement and repealing
Regulation (EC) No 1987/2006 (published in
OJ L 312, 7.12.2018, p. 14).
(c)
Regulation (EU) 2018/1862 details the SIS's use in police and judicial cooperation in criminal matters, amending
Council Decision 2007/533/JHA and repealing both
Regulation (EC) No 1986/2006 and
Commission Decision 2010/261/EU (published in
OJ L 312, 7.12.2018, p. 56).
Additionally, on 7 July 2021, the
European Parliament and Council adopted
Regulation (EU) 2021/1133, which amends several previous regulations to establish conditions for accessing other EU information systems for the Visa Information System.
of the Council of 28 November 2018 on the use of
the Schengen Information System for the return of illegally staying third-country nationals (OJ L 312,
7.12.2018, p. 1).
(b) Regulation (EU) 2018/1861 of the European Parliament and of the Council of 28 November 2018 on the
establishment, operation and use of the Schengen Information System (SIS) in the field of border checks, and
amending the Convention implementing the Schengen Agreement, and amending and repealing Regulation (EC)
No 1987/2006 (OJ L 312, 7.12.2018, p. 14).
(c) Regulation (EU) 2018/1862 of the European Parliament and of the Council of 28 November 2018 on the
establishment, operation and use of the Schengen Information System (SIS) in the field of police cooperation and
judicial cooperation in criminal matters, amending and repealing Council Decision 2007/533/JHA, and
repealing Regulation (EC) No 1986/2006 of the European Parliament and of the Council and Commission
Decision 2010/261/EU (OJ L 312, 7.12.2018, p. 56).
2.
Visa Information System
(a) Regulation (EU) 2021/1133 of the European Parliament and of the Council of 7 July 2021 amending
Regulations (EU) No 603/2013, (EU) 2016/794, (EU) 2018/1862, (EU) 2019/816 and (EU) 2019/818 as regards
the establishment of the conditions for accessing other EU information systems for the purposes of the Visa
Information System (OJ L
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On July 13, 2021, the
European Parliament and Council adopted
Regulation (EU) 2021/1134, which amends several previous regulations related to the Visa Information System. This
regulation aims to improve access to EU information systems for visa purposes and repeals certain earlier decisions (2004/512/EC and 2008/633/JHA). Additionally, on May 14, 2024,
Regulation (EU) 2024/1358 was established to create 'Eurodac,' a system for comparing
biometric data. This
regulation helps implement other EU regulations and directives to identify illegally residing third-country nationals and stateless persons. It also allows
law enforcement authorities and
Europol to request comparisons with Eurodac
data for
law enforcement purposes, while amending Regulations (EU) 2018/1240 and (EU) 2019/818.
8/1862, (EU) 2019/816 and (EU) 2019/818 as regards
the establishment of the conditions for accessing other EU information systems for the purposes of the Visa
Information System (OJ L 248, 13.7.2021, p. 1).
(b) Regulation (EU) 2021/1134 of the European Parliament and of the Council of 7 July 2021 amending
Regulations (EC) No 767/2008, (EC) No 810/2009, (EU) 2016/399, (EU) 2017/2226, (EU) 2018/1240, (EU)
2018/1860, (EU) 2018/1861, (EU) 2019/817 and (EU) 2019/1896 of the European Parliament and of the
Council and repealing Council Decisions 2004/512/EC and 2008/633/JHA, for the purpose of reforming the
Visa Information System (OJ L 248, 13.7.2021, p. 11).
3.
Eurodac
Regulation (EU) 2024/1358 of the European Parliament and of the Council of 14 May 2024 on the establishment of
‘Eurodac’ for the comparison of biometric data in order to effectively apply Regulations (EU) 2024/1315 and (EU)
2024/1350 of the European Parliament and of the Council and Council Directive 2001/55/EC and to identify
illegally staying third-country nationals and stateless persons and on requests for the comparison with Eurodac data
by Member States’ law enforcement authorities and Europol for law enforcement purposes, amending Regulations
(EU) 2018/1240 and (EU) 2019/818
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This text discusses various regulations related to
law enforcement and border control in the
European Union. It mentions the following key points:
1. **Comparison with Eurodac
Data**: There are requests from
law enforcement authorities in
Member States and
Europol to compare
data with Eurodac for
law enforcement purposes. This involves amending Regulations (EU) 2018/1240 and (EU) 2019/818, while repealing
Regulation (EU) No 603/2013. This information is published in the Official Journal (
OJ L, 2024/1358, 22.5.2024).
2. **Entry/Exit System (EES)**:
Regulation (EU) 2017/2226, established on November 30, 2017, creates an Entry/Exit System to track the entry and exit of third-country nationals at the external borders of
Member States. It also sets conditions for
law enforcement access to this
data and amends the Schengen Agreement and other related regulations (
OJ L 327, 9.12.2017).
3. **European Travel Information and Authorisation System (ETIAS)**:
Regulation (EU) 2018/1240, enacted on September 12, 2018, establishes ETIAS and amends several other regulations related to travel and border control (
OJ L 236, 19.9.2018).
less persons and on requests for the comparison with Eurodac data
by Member States’ law enforcement authorities and Europol for law enforcement purposes, amending Regulations
(EU) 2018/1240 and (EU) 2019/818 of the European Parliament and of the Council and repealing Regulation (EU)
No 603/2013 of the European Parliament and of the Council (OJ L, 2024/1358, 22.5.2024, ELI: http://data.europa.
eu/eli/reg/2024/1358/oj).
4.
Entry/Exit System
Regulation (EU) 2017/2226 of the European Parliament and of the Council of 30 November 2017 establishing an
Entry/Exit System (EES) to register entry and exit data and refusal of entry data of third-country nationals crossing
the external borders of the Member States and determining the conditions for access to the EES for law enforcement
purposes, and amending the Convention implementing the Schengen Agreement and Regulations (EC)
No 767/2008 and (EU) No 1077/2011 (OJ L 327, 9.12.2017, p. 20).
5.
European Travel Information and Authorisation System
(a) Regulation (EU) 2018/1240 of the European Parliament and of the Council of 12 September 2018 establishing
a European Travel Information and Authorisation System (ETIAS) and amending Regulations (EU)
No 1077/2011, (EU) No 515/2014, (EU) 2016/399, (EU) 2016/1624 and (EU) 2017/2226 (OJ L 236,
19.9.2018, p. 1).
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The following regulations are important for understanding EU policies:
1. Regulations (EU) 2016/399, (EU) 2016/1624, and (EU) 2017/2226 were published in the Official Journal (
OJ L 236) on September 19, 2018.
2.
Regulation (EU) 2018/1241, adopted by the
European Parliament and Council on September 12, 2018, amends
Regulation (EU) 2016/794 to create the European Travel Information and Authorisation System (ETIAS), also published in
OJ L 236 on September 19, 2018.
3.
Regulation (EU) 2019/816, established on April 17, 2019, creates a centralized system (ECRIS-TCN) to identify
Member States that hold conviction information on third-country nationals and stateless persons. This
regulation amends
Regulation (EU) 2018/1726 and was published in
OJ L 135 on May 22, 2019.
4.
Regulation (EU) 2019/817, adopted on May 20, 2019, sets up a framework for interoperability between EU information systems related to borders and visas. It amends several previous regulations, including (EC) No 767/2008, (EU) 2016/399, (EU) 2017/2226, (EU) 2018/1240, (EU) 2018/1726, and (EU) 2018/1861.
4, (EU) 2016/399, (EU) 2016/1624 and (EU) 2017/2226 (OJ L 236,
19.9.2018, p. 1).
(b) Regulation (EU) 2018/1241 of the European Parliament and of the Council of 12 September 2018 amending
Regulation (EU) 2016/794 for the purpose of establishing a European Travel Information and Authorisation
System (ETIAS) (OJ L 236, 19.9.2018, p. 72).
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6.
European Criminal Records Information System on third-country nationals and stateless persons
Regulation (EU) 2019/816 of the European Parliament and of the Council of 17 April 2019 establishing
a centralised system for the identification of Member States holding conviction information on third-country
nationals and stateless persons (ECRIS-TCN) to supplement the European Criminal Records Information System and
amending Regulation (EU) 2018/1726 (OJ L 135, 22.5.2019, p. 1).
7.
Interoperability
(a) Regulation (EU) 2019/817 of the European Parliament and of the Council of 20 May 2019 on establishing
a framework for interoperability between EU information systems in the field of borders and visa and amending
Regulations (EC) No 767/2008, (EU) 2016/399, (EU) 2017/2226, (EU) 2018/1240, (EU) 2018/1726 and (EU)
2018/1861 of the
Show original text
(EU) Regulations 2016/399, 2017/2226, 2018/1240, 2018/1726, and 2018/1861, along with
Council Decisions 2004/512/EC and 2008/633/JHA, are documented in
OJ L 135, dated May 22, 2019, page 27. Additionally,
Regulation (EU) 2019/818, established on May 20, 2019, creates a framework for interoperability among EU information systems related to police and judicial cooperation,
asylum, and
migration. This
regulation also amends Regulations (EU) 2018/1726, 2018/1862, and 2019/816, as noted in
OJ L 135, dated May 22, 2019, page 85. The
technical documentation mentioned in
Article 53(1), point (a), for
providers of
general-purpose AI models must include specific information based on the model's size and risk profile.
(EU) 2016/399, (EU) 2017/2226, (EU) 2018/1240, (EU) 2018/1726 and (EU)
2018/1861 of the European Parliament and of the Council and Council Decisions 2004/512/EC and
2008/633/JHA (OJ L 135, 22.5.2019, p. 27).
(b) Regulation (EU) 2019/818 of the European Parliament and of the Council of 20 May 2019 on establishing
a framework for interoperability between EU information systems in the field of police and judicial cooperation,
asylum and migration and amending Regulations (EU) 2018/1726, (EU) 2018/1862 and (EU) 2019/816 (OJ
L 135, 22.5.2019, p. 85).
EN
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ELI: http://data.europa.eu/eli/reg/2024/1689/oj
ANNEX XI
Technical documentation referred to in Article 53(1), point (a) — technical documentation for
providers of general-purpose AI models
Section 1
Information to be provided by all providers of general-purpose AI models
The technical documentation referred to in Article 53(1), point (a) shall contain at least the following information as
appropriate to the size and risk profile of the model:
1.
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All
providers of
general-purpose AI models must provide
technical documentation as outlined in
Article 53(1), point (a). This documentation should include the following information, tailored to the model's size and risk profile:
1. A general description of the
AI model, which should cover:
(a) The tasks the model is designed to perform and the types of
AI systems it can be integrated with;
(b) The
acceptable use policies;
(c) The release date and distribution methods;
(d) The model's architecture and number of
parameters;
(e) The input and output formats (e.g., text, image);
(f) The licensing information.
2. A detailed description of the model's components and the development process, including:
(a) The technical requirements (e.g., usage instructions, infrastructure, tools) needed for integration into
AI systems;
(b) The design specifications and training process, including methodologies, key design choices, optimization goals, and the significance of various
parameters;
(c) Information about the
data used for training, testing, and validation, including
data type, source, curation methods (e.g., cleaning, filtering), number of
data points, and measures to identify unsuitable
data sources and biases;
(d) The
computational resources used for training (e.g.,
floating point operations), training duration, and other relevant training details;
(e) The known or estimated
energy consumption of the model.
to be provided by all providers of general-purpose AI models
The technical documentation referred to in Article 53(1), point (a) shall contain at least the following information as
appropriate to the size and risk profile of the model:
1.
A general description of the general-purpose AI model including:
(a) the tasks that the model is intended to perform and the type and nature of AI systems in which it can be
integrated;
(b) the acceptable use policies applicable;
(c) the date of release and methods of distribution;
(d) the architecture and number of parameters;
(e) the modality (e.g. text, image) and format of inputs and outputs;
(f) the licence.
2.
A detailed description of the elements of the model referred to in point 1, and relevant information of the process
for the development, including the following elements:
(a) the technical means (e.g. instructions of use, infrastructure, tools) required for the general-purpose AI model to
be integrated in AI systems;
(b) the design specifications of the model and training process, including training methodologies and techniques,
the key design choices including the rationale and assumptions made; what the model is designed to optimise for
and the relevance of the different parameters, as applicable;
(c) information on the data used for training, testing and validation, where applicable, including the type and
provenance of data and curation methodologies (e.g. cleaning, filtering, etc.), the number of data points, their
scope and main characteristics; how the data was obtained and selected as well as all other measures to detect the
unsuitability of data sources and methods to detect identifiable biases, where applicable;
(d) the computational resources used to train the model (e.g. number of floating point operations), training time,
and other relevant details related to the training;
(e) known or estimated energy consumption of the model.
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The following information must be provided by
providers of
general-purpose AI models that may pose
systemic risks:
1. A clear description of any identifiable biases in the model, if applicable.
2. Details about the
computational resources used for training the model, such as the number of
floating point operations, training duration, and other relevant training information.
3. Information on the known or estimated
energy consumption of the model. If the
energy consumption is not known, it can be estimated based on the
computational resources used.
Additionally,
providers must include:
1. A detailed explanation of the
evaluation strategies used, including results based on public evaluation protocols or other methods. This should cover evaluation criteria, metrics, and how limitations were identified.
2. A description of any measures taken for internal or external adversarial testing (like red teaming) and any model adjustments, including alignment and
fine-tuning.
3. An explanation of the
system architecture, detailing how software components interact and integrate into the overall processing.
This information is outlined in
Article 53(1), point (b) of the
regulation, and is essential for downstream
providers who integrate the model into their
AI systems.
identifiable biases, where applicable;
(d) the computational resources used to train the model (e.g. number of floating point operations), training time,
and other relevant details related to the training;
(e) known or estimated energy consumption of the model.
With regard to point (e), where the energy consumption of the model is unknown, the energy consumption may be
based on information about computational resources used.
Section 2
Additional information to be provided by providers of general-purpose AI models with systemic risk
1.
A detailed description of the evaluation strategies, including evaluation results, on the basis of available public
evaluation protocols and tools or otherwise of other evaluation methodologies. Evaluation strategies shall include
evaluation criteria, metrics and the methodology on the identification of limitations.
2.
Where applicable, a detailed description of the measures put in place for the purpose of conducting internal and/or
external adversarial testing (e.g. red teaming), model adaptations, including alignment and fine-tuning.
OJ L, 12.7.2024
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3.
Where applicable, a detailed description of the system architecture explaining how software components build or
feed into each other and integrate into the overall processing.
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ELI: http://data.europa.eu/eli/reg/2024/1689/oj
ANNEX XII
Transparency information referred to in Article 53(1), point (b) — technical documentation for
providers of general-purpose AI models to downstream providers that integrate the model into their
AI system
The information referred to in Article 53(1), point (b) shall contain at least the following:
1.
Show original text
b)
Technical documentation for
providers of
general-purpose AI models to those who integrate these models into their
AI systems. According to
Article 53(1), point (b), this documentation must include at least the following information: 1. A general description of the
AI model, which should cover: (a) the tasks the model is designed to perform and the types of
AI systems it can be integrated into; (b) the
acceptable use policies; (c) the release date and distribution methods; (d) how the model interacts with external
hardware or software, if applicable; (e) the versions of relevant software related to the model's use, if applicable; (f) the model's architecture and number of
parameters; (g) the type (e.g., text, image) and format of inputs and outputs; (h) the model's license. 2. A description of the model's components and its development process, which should include: (a) the technical requirements (e.g., usage instructions, infrastructure, tools) needed for integrating the model into
AI systems; (b) the type and format of inputs and outputs, including their maximum size (e.g., context window length); (c) details about the
data used for training, testing, and validation, including the type, source, and curation methods of the
data.
b) — technical documentation for
providers of general-purpose AI models to downstream providers that integrate the model into their
AI system
The information referred to in Article 53(1), point (b) shall contain at least the following:
1.
A general description of the general-purpose AI model including:
(a) the tasks that the model is intended to perform and the type and nature of AI systems into which it can be
integrated;
(b) the acceptable use policies applicable;
(c) the date of release and methods of distribution;
(d) how the model interacts, or can be used to interact, with hardware or software that is not part of the model
itself, where applicable;
(e) the versions of relevant software related to the use of the general-purpose AI model, where applicable;
(f) the architecture and number of parameters;
(g) the modality (e.g. text, image) and format of inputs and outputs;
(h) the licence for the model.
2.
A description of the elements of the model and of the process for its development, including:
(a) the technical means (e.g. instructions for use, infrastructure, tools) required for the general-purpose AI model to
be integrated into AI systems;
(b) the modality (e.g. text, image, etc.) and format of the inputs and outputs and their maximum size (e.g. context
window length, etc.);
(c) information on the data used for training, testing and validation, where applicable, including the type and
provenance of data and curation methodologies.
OJ L, 12.7.
Show original text
This document outlines the criteria for identifying
general-purpose AI models that may pose
systemic risks, as mentioned in
Article 51. The
European Commission will consider the following factors to determine if an
AI model meets the criteria: (a) the number of
parameters in the model; (b) the quality or size of the
training data set, which can be measured in tokens; (c) the
computational resources used for training, assessed through
floating point operations or other indicators like training cost, time, or
energy consumption; (d) the types of inputs and outputs the model can handle, such as text-to-text or text-to-image, and the standards for
high-impact capabilities; (e) the model's performance on
benchmarks, including its ability to perform tasks without extra training, learn new tasks, and its autonomy and scalability; (f) its potential impact on the
internal market, which is assumed if it has at least 10,000
registered business users in the EU; and (g) the total number of
registered end-users.
.g. context
window length, etc.);
(c) information on the data used for training, testing and validation, where applicable, including the type and
provenance of data and curation methodologies.
OJ L, 12.7.2024
EN
ELI: http://data.europa.eu/eli/reg/2024/1689/oj
143/144
ANNEX XIII
Criteria for the designation of general-purpose AI models with systemic risk referred to in Article 51
For the purpose of determining that a general-purpose AI model has capabilities or an impact equivalent to those set out in
Article 51(1), point (a), the Commission shall take into account the following criteria:
(a)
the number of parameters of the model;
(b)
the quality or size of the data set, for example measured through tokens;
(c)
the amount of computation used for training the model, measured in floating point operations or indicated by
a combination of other variables such as estimated cost of training, estimated time required for the training, or
estimated energy consumption for the training;
(d)
the input and output modalities of the model, such as text to text (large language models), text to image,
multi-modality, and the state of the art thresholds for determining high-impact capabilities for each modality, and
the specific type of inputs and outputs (e.g. biological sequences);
(e)
the benchmarks and evaluations of capabilities of the model, including considering the number of tasks without
additional training, adaptability to learn new, distinct tasks, its level of autonomy and scalability, the tools it has
access to;
(f)
whether it has a high impact on the internal market due to its reach, which shall be presumed when it has been
made available to at least 10 000 registered business users established in the Union;
(g)
the number of registered end-users.
EN
OJ L, 12.7.
Show original text
to its reach, which shall be presumed when it has been
made available to at least 10 000 registered business users established in the Union;
(g)
the number of registered end-users.
EN
OJ L, 12.7.2024
144/144
ELI: http://data.europa.eu/eli/reg/2024/1689/oj
Entities
10 000 registered business users
A threshold indicating the number of users required for the regulation's reach to be presumed.
- ← reg/2024/1689/oj: The regulation lays down rules regarding the number of registered business users for its presumed reach.
10 years
The duration for which importers must keep documentation related to high-risk AI systems.
- ← importer: Importers are required to keep documentation for a period of 10 years.
13 June 2024
June 13, 2024, is the date on which Regulation (EU) 2024/1689 was adopted.
15 calendar days
The time frame within which objections must be raised by Member States or the Commission regarding an authorization.
- ← Member States: Member States have a period of 15 calendar days to raise objections regarding authorizations.
15 days
The maximum time frame within which providers must report serious incidents after becoming aware of them.
- ← serious incident: Providers must report serious incidents within 15 days of awareness.
17 April 2019
The date when Directive (EU) 2019/790 was adopted.
18 June 2021
The date on which the joint opinion of the European Data Protection Supervisor and Board was delivered.
2 August 2025
The deadline for the governance and conformity assessment system to be operational and for obligations regarding general-purpose AI models to apply.
- ← Regulation: The governance and conformity assessment system for general-purpose AI models must be operational by 2 August 2025.
- ← Regulation 2024/1689: Provisions on penalties in Regulation 2024/1689 will take effect from 2 August 2025.
- ← Member States: By August 2, 2025, Member States must publicly provide information on their designated competent authorities as part of their obligations under the Regulation.
- ← Commission: The Commission is required to issue guidance by the specified date.
2 August 2026
The date from which the Regulation will fully apply and Member States must ensure operational AI regulatory sandboxes.
- ← Regulation: The Regulation will be applicable from 2 August 2026, requiring compliance from high-risk AI systems after this date.
- ← AI regulatory sandboxes: AI regulatory sandboxes must be operational by 2 August 2026.
- ← AI regulatory sandbox: The operational deadline for the AI regulatory sandboxes established by Member States.
- ← Regulation 2024/1689: The regulation applies from this date.
2 August 2027
The date by which AI systems must be placed on the market to be subject to compliance requirements, and from which certain obligations in the regulation apply.
- ← Artificial Intelligence Act: The date before which AI systems must be placed on the market to comply with the regulation.
- ← Regulation: The Regulation requires compliance by this date for large-scale IT systems.
- ← Regulation 2024/1689: Article 6(1) and corresponding obligations apply from this date.
2 August 2028
The deadline for the Commission to evaluate and report on amendments to the list of high-risk areas and the functioning of the AI Office.
- ← Commission: The Commission is required to evaluate and report on potential amendments to high-risk areas by 2 August 2028.
2 August 2029
The deadline for the Commission to evaluate and review the Regulation.
- ← Commission: The Commission must evaluate and review the Regulation by 2 August 2029.
2 August 2030
The compliance deadline for operators of certain AI systems to meet the requirements of the Regulation.
- ← Regulation: Operators of certain AI systems must comply with the Regulation by this date.
- ← Regulation: Providers and deployers of high-risk AI systems must comply with the Regulation by this date.
2 August 2031
The deadline by which the Commission must assess the enforcement of the Regulation.
- ← Regulation: The Commission must assess the enforcement of the Regulation by 2 August 2031.
2 February 2025
The date from which prohibitions and general provisions of the Regulation will apply due to unacceptable risks.
- ← Regulation: Prohibitions and general provisions of the Regulation should apply from this date due to unacceptable risks.
- ← Regulation 2024/1689: Chapters I and II of the regulation apply from this date.
2 February 2026
This date marks the deadline for the Commission to adopt an implementing act for the post-market monitoring plan.
- ← Commission: The Commission is required to provide guidelines and adopt an implementing act by 2 February 2026.
2 May 2025
The deadline by which codes of practice should be ready to enable compliance demonstration.
2009/48/EC
Directive of the European Parliament and of the Council on the safety of toys, established on 18 June 2009.
- → 2009-06-18: The directive was established on this date.
2017/746
This Regulation establishes a governance framework for coordinating and supporting the application of AI regulations at both national and Union levels.
- → AI Office: The effective implementation of Regulation 2017/746 requires the establishment of the AI Office.
2019 Ethics Guidelines for Trustworthy AI
Guidelines developed by the AI HLEG outlining seven non-binding ethical principles for ensuring AI is trustworthy and ethically sound.
- ← AI HLEG: The AI HLEG proposed ethical guidelines to ensure AI systems are trustworthy.
2024/1689
A regulation proposed to lay down uniform obligations for operators regarding the use of AI systems within the internal market.
- → AI systems: The regulation lays down uniform obligations for operators regarding the use of AI systems.
- → Article 114 TFEU: The regulation is based on Article 114 of the TFEU to ensure the functioning of the internal market.
- → Article 16 TFEU: The regulation includes specific rules based on Article 16 TFEU concerning the protection of personal data.
- → personal data: The regulation contains specific rules on the protection of personal data in relation to AI systems.
- → law enforcement: The regulation addresses the use of AI systems in the context of law enforcement.
- → European Data Protection Board: The regulation proposes to consult the European Data Protection Board regarding specific rules.
31 December 2030
The deadline for AI systems placed on the market before 2 August 2027 to comply with the new regulation.
- ← Artificial Intelligence Act: The compliance deadline for AI systems placed on the market before 2 August 2027.
- ← Regulation: The Regulation sets this date as the final compliance deadline for large-scale IT systems.
7 %
The percentage of total worldwide annual turnover that can be imposed as a fine for undertakings in case of non-compliance.
- ← Article 99: Article 99 states that fines for undertakings can be up to 7% of their total worldwide annual turnover.
acceptable use policies
Policies that define the acceptable ways in which the general-purpose AI model can be used.
accountability framework
A framework that outlines the responsibilities of management and staff regarding various aspects of high-risk AI systems.
- → high-risk AI system: The accountability framework is essential for defining responsibilities related to high-risk AI systems.
Accreditation Certificate
A document issued by a national accreditation body certifying that a conformity assessment body complies with established requirements.
accuracy
Accuracy is a measure of how closely a computed or measured value aligns with the true value, particularly relevant in the context of AI systems.
- ← AI regulatory sandboxes: AI regulatory sandboxes assess the accuracy of AI systems as part of their benchmarking and testing processes.
administrative fine
An administrative fine is a financial penalty imposed on operators for infringements of the regulation, which can be up to EUR 1,500,000.
- → operator: Administrative fines are imposed on operators for infringements, affecting their market operations.
- ← AI system: The purpose of the AI system is considered when determining the amount of administrative fines.
- ← Article 5: Article 5 specifies the prohibited AI practices that can lead to administrative fines.
advisory forum
The advisory forum is a consultative body that provides technical expertise and advice to the European Commission on AI regulation and standardisation requests.
- ← European Commission: The European Commission consults the advisory forum to collect relevant expertise for standardisation requests.
- → Fundamental Rights Agency: The Fundamental Rights Agency is a permanent member of the advisory forum.
- → ENISA: ENISA is a permanent member of the advisory forum.
- → CEN: CEN is a permanent member of the advisory forum.
- → CENELEC: CENELEC is a permanent member of the advisory forum.
- → ETSI: ETSI is a permanent member of the advisory forum.
affected persons
Individuals who are impacted by decisions made with the assistance of AI systems.
- ← AI literacy: AI literacy aims to improve the understanding of affected persons regarding AI decisions.
AI
A fast-evolving family of technologies that contributes to various economic, environmental, and societal benefits.
- → Treaty on European Union (TEU): AI development should align with the values enshrined in the Treaty on European Union.
- → Charter: AI should respect the fundamental rights and freedoms outlined in the Charter.
AI ecosystem
The network of actors involved in the development and deployment of AI technologies, which may include various stakeholders cooperating within the regulatory framework.
- ← AI regulatory sandbox: AI regulatory sandboxes are designed to foster innovation within the AI ecosystem.
AI HLEG
The High-Level Expert Group on Artificial Intelligence provides guidelines and ethical frameworks for the development of trustworthy AI.
AI literacy
The knowledge and skills necessary to understand and effectively engage with AI systems, including their development and application.
- → AI systems: AI literacy proposes equipping users with the necessary knowledge to engage with AI systems effectively.
- → affected persons: AI literacy aims to improve the understanding of affected persons regarding AI decisions.
- → Regulation: AI literacy aims to improve compliance and enforcement of the Regulation.
- ← AI regulatory sandbox: The AI regulatory sandbox aims to improve AI literacy among providers and users.
- → AI systems: AI literacy aims to improve the informed deployment of AI systems.
- ← codes of conduct: Codes of conduct may promote AI literacy among users and developers.
AI literacy
The knowledge necessary for relevant actors in the AI value chain to understand the implications of AI decisions and ensure compliance.
- → AI systems: AI literacy proposes equipping users with the necessary knowledge to engage with AI systems effectively.
- → affected persons: AI literacy aims to improve the understanding of affected persons regarding AI decisions.
- → Regulation: AI literacy aims to improve compliance and enforcement of the Regulation.
- ← AI regulatory sandbox: The AI regulatory sandbox aims to improve AI literacy among providers and users.
- → AI systems: AI literacy aims to improve the informed deployment of AI systems.
- ← codes of conduct: Codes of conduct may promote AI literacy among users and developers.
AI literacy
The level of understanding and competence in using AI systems required for those involved in their development and operation.
- → AI systems: AI literacy proposes equipping users with the necessary knowledge to engage with AI systems effectively.
- → affected persons: AI literacy aims to improve the understanding of affected persons regarding AI decisions.
- → Regulation: AI literacy aims to improve compliance and enforcement of the Regulation.
- ← AI regulatory sandbox: The AI regulatory sandbox aims to improve AI literacy among providers and users.
- → AI systems: AI literacy aims to improve the informed deployment of AI systems.
- ← codes of conduct: Codes of conduct may promote AI literacy among users and developers.
AI literacy
Skills and knowledge that enable individuals to understand and engage with AI systems effectively.
- → AI systems: AI literacy proposes equipping users with the necessary knowledge to engage with AI systems effectively.
- → affected persons: AI literacy aims to improve the understanding of affected persons regarding AI decisions.
- → Regulation: AI literacy aims to improve compliance and enforcement of the Regulation.
- ← AI regulatory sandbox: The AI regulatory sandbox aims to improve AI literacy among providers and users.
- → AI systems: AI literacy aims to improve the informed deployment of AI systems.
- ← codes of conduct: Codes of conduct may promote AI literacy among users and developers.
AI literacy
Skills, knowledge, and understanding that enable providers, deployers, and affected persons to make informed decisions regarding the deployment of AI systems.
- → AI systems: AI literacy proposes equipping users with the necessary knowledge to engage with AI systems effectively.
- → affected persons: AI literacy aims to improve the understanding of affected persons regarding AI decisions.
- → Regulation: AI literacy aims to improve compliance and enforcement of the Regulation.
- ← AI regulatory sandbox: The AI regulatory sandbox aims to improve AI literacy among providers and users.
- → AI systems: AI literacy aims to improve the informed deployment of AI systems.
- ← codes of conduct: Codes of conduct may promote AI literacy among users and developers.
AI model
A specific implementation of an AI system that can generate content, including general-purpose models.
- ← AI system: AI systems may include safeguards to ensure compliance with regulations regarding content generation.
AI models
AI models are specific implementations of artificial intelligence systems that can be marketed or used within the Union, often involving the processing of personal data.
AI models
Specific types of AI systems developed for scientific research and development.
AI Office
An authority responsible for overseeing compliance, monitoring AI models, and facilitating the development of codes of practice related to AI systems.
- ← general-purpose AI model: Providers of general-purpose AI models must prepare technical documentation and notify the AI Office about the model's classification and systemic risks.
- → general-purpose AI models: The AI Office monitors compliance and possible infringements related to providers of general-purpose AI models.
- → scientific community: The AI Office engages with the scientific community to inform the assessment of AI models.
- → general-purpose AI model: The AI Office acts in accordance with the regulations concerning the classification of AI models with systemic risks.
- ← Regulation: The Regulation empowers the AI Office to monitor compliance and classify AI models.
- → scientific panel: The AI Office receives alerts and opinions from the scientific panel regarding AI models.
- → codes of practice: The AI Office proposes the establishment and adaptation of codes of practice to facilitate compliance with transparency obligations and ensure proper application of regulations for AI models.
- → Scientific Panel: The AI Office collaborates with the Scientific Panel for the development of codes of practice.
- → codes of practice: The AI Office is responsible for approving codes of practice to ensure they meet compliance standards.
- ← 2017/746: The effective implementation of Regulation 2017/746 requires the establishment of the AI Office.
- → Digital Single Market: The AI Office aims to strengthen the functioning of the Digital Single Market.
- → EuroHPC Joint Undertaking: The AI Office will make use of existing resources and expertise, including synergies with the EuroHPC Joint Undertaking.
- → Digital Europe Programme: The AI Office will leverage synergies with the AI testing and experimentation facilities under the Digital Europe Programme.
- ← Commission Decision of 24.1.2024: The Commission Decision of 24.1.2024 establishes the AI Office.
- → Scientific Panel: The AI Office requires the establishment of a Scientific Panel to support monitoring activities.
- → joint investigations: The AI Office provides coordination support for joint investigations conducted by market surveillance authorities.
- → Regulation (EU) 2019/1020: The AI Office operates under the framework established by Regulation (EU) 2019/1020 to monitor AI systems.
- ← market surveillance authorities: Market surveillance authorities can request assistance from the AI Office for investigations related to high-risk AI systems.
- → Regulation: The AI Office operates in compliance with the Regulation's requirements.
- ← scientific panel: The scientific panel advises and supports the AI Office in monitoring activities and enforcing the Regulation.
- → independent experts: The AI Office can involve independent experts to carry out evaluations on its behalf.
- → law enforcement authority: The AI Office contributes to the implementation and monitoring of AI systems, which may include law enforcement authorities.
- ← national competent authority: National competent authorities transmit information regarding AI systems to the AI Office.
- ← OJ L, 12.7.2024: The regulation published in the Official Journal on this date includes provisions related to the AI Office.
- ← Commission Decision of 24 January 2024: The decision that established the AI Office was made on this date.
- → high-risk AI systems: The AI Office proposes voluntary model terms for contracts related to high-risk AI systems.
- → deployers: The AI Office aims to improve compliance for deployers through the development of templates and automated tools.
- ← general-purpose AI models: Providers must submit technical documentation to the AI Office.
- ← general-purpose AI model: Providers of general-purpose AI models must transmit documentation to the AI Office.
- → Article 78: The AI Office must treat information in accordance with the confidentiality obligations set out in Article 78.
- → Regulation 2024/1689: The AI Office is responsible for addressing issues related to compliance with Regulation 2024/1689.
- ← general-purpose AI models with systemic risk: Providers must report relevant information to the AI Office.
- → general-purpose AI models: The AI Office may invite providers of general-purpose AI models to participate in the development of codes of practice.
- → codes of practice: The AI Office aims to ensure that the codes of practice are effective and meet the needs of all stakeholders.
- → general-purpose AI models: The AI Office invites providers of general-purpose AI models to adhere to the codes of practice.
- → Union: The AI Office reports its assessments and findings to the Union regarding the codes of practice.
- → Article 53: The AI Office requires adherence to the obligations outlined in Article 53 for AI model providers.
- ← AI regulatory sandboxes: Decisions regarding the suspension of testing processes in AI regulatory sandboxes are communicated to the AI Office.
- ← AI regulatory sandbox: The AI regulatory sandbox informs the AI Office about its establishment and operations.
- → AI regulatory sandbox: The AI Office provides support and guidance to national competent authorities regarding the AI regulatory sandbox.
- ← National competent authorities: National competent authorities submit annual reports to the AI Office.
- → AI regulatory sandbox: The AI Office encourages interaction in AI regulatory sandboxes.
- → Article 62: The AI Office is tasked with actions that align with the provisions of Article 62.
- ← Union: The AI Office serves all operators across the Union, providing information related to AI regulation.
- ← Regulation 2024/1689: The regulation proposes the development of the AI Office to enhance AI capabilities.
- ← Article 64: Article 64 outlines the governance structure related to the AI Office.
- ← Member States: Member States shall facilitate the tasks entrusted to the AI Office as reflected in the regulation.
- ← Board: The AI Office is responsible for preparing the agenda and providing secretariat support for the Board.
- → Member States: The AI Office assists Member States in developing AI regulatory sandboxes.
- ← Article 90: Article 90 requires the scientific panel to alert the AI Office of possible systemic risks.
- ← scientific panel: The scientific panel may request assistance from the AI Office for the performance of its tasks.
- → Chapter III, Section 2: The AI Office proposes monitoring compliance of AI systems based on the requirements outlined in Chapter III, Section 2.
- → high-risk AI systems: The AI Office requires documentation to assess compliance of high-risk AI systems.
- ← Commission: The Commission entrusts the AI Office with the implementation of supervision and enforcement tasks.
- → Regulation 2024/1689: The AI Office acts in accordance with Regulation 2024/1689 to monitor compliance.
- ← scientific panel: The scientific panel transmits alerts regarding systemic risks to the AI Office.
- ← Commission: The Commission may exercise powers and inform the AI Office about assessments.
- → Board: The AI Office informs the Board of any measures taken in response to alerts.
- ← Articles 91 to 94: Articles 91 to 94 lay down the rules for the powers of the AI Office.
- → Article 92: The AI Office conducts evaluations as outlined in Article 92.
- → general-purpose AI model: The AI Office requires documentation and access to the general-purpose AI model for evaluations.
- → general-purpose AI model: The AI Office may initiate a structured dialogue with the provider of the general-purpose AI model.
- → general-purpose AI model: The AI Office may initiate a structured dialogue with the provider of the general-purpose AI model.
- → codes of conduct: The AI Office encourages the drawing up of codes of conduct for the voluntary application of AI requirements.
- → codes of conduct: The AI Office facilitates the development of codes of conduct for AI systems.
- → SMEs: The AI Office considers the specific interests and needs of SMEs when developing codes of conduct.
- ← Commission: The Commission shall evaluate the functioning of the AI Office by 2 August 2028.
- ← Regulation: The Regulation lays down rules for the establishment and functioning of the AI Office.
- → Regulation: The AI Office is tasked with developing methodologies for evaluating risk levels based on the Regulation.
AI practices
Practices involving artificial intelligence that may be subject to regulation under Union law.
- ← Member State: Member States must take appropriate measures regarding AI practices if deemed justified by the Commission.
AI Regulation
A set of binding rules for AI systems aimed at ensuring ethical and professional standards in research and development activities.
- → AI Systems: The regulation establishes rules that AI systems must follow.
- → OJ L: The regulation is published in the Official Journal of the European Union on the specified date.
- ← AI HLEG: The guidelines developed by the AI HLEG align with the principles set out in the regulation.
AI regulatory sandbox
A controlled environment established by national competent authorities to facilitate the development, testing, and validation of innovative AI systems under regulatory oversight, ensuring compliance with regulations.
- ← AI systems: AI systems require a regulatory sandbox for development and testing under oversight.
- ← Member States: Member States are responsible for establishing AI regulatory sandboxes to facilitate AI innovation at the national level.
- → innovative AI systems: The AI regulatory sandbox provides a controlled environment for the development and testing of innovative AI systems.
- → SMEs: The AI regulatory sandbox aims to enhance accessibility for SMEs to foster innovation.
- → Union law: The AI regulatory sandbox operates to ensure compliance with Union law.
- → national competent authorities: The AI regulatory sandbox should cooperate with national competent authorities to ensure effective supervision.
- ← common rules for AI regulatory sandboxes: Common rules are established to ensure uniform implementation of AI regulatory sandboxes.
- → European Digital Innovation Hubs: The AI regulatory sandbox may involve European Digital Innovation Hubs to support innovation.
- → Regulation (EU) 2016/679: The AI regulatory sandbox operates under the rules established by Regulation (EU) 2016/679.
- → Regulation (EU) 2018/1725: The AI regulatory sandbox operates under the rules established by Regulation (EU) 2018/1725.
- → Directive (EU) 2016/680: The AI regulatory sandbox operates under the rules established by Directive (EU) 2016/680.
- → personal data: The AI regulatory sandbox allows the use of personal data for developing AI systems under specified conditions.
- ← real-world testing plan: The real-world testing plan is necessary for conducting tests within the AI regulatory sandbox.
- ← sandbox plan: The sandbox plan outlines the conditions and requirements for activities in the AI regulatory sandbox.
- → AI literacy: The AI regulatory sandbox aims to improve AI literacy among providers and users.
- → 2 August 2026: The operational deadline for the AI regulatory sandboxes established by Member States.
- ← European Data Protection Supervisor: The European Data Protection Supervisor may establish an AI regulatory sandbox for Union institutions.
- → AI ecosystem: AI regulatory sandboxes are designed to foster innovation within the AI ecosystem.
- ← competent authority: The competent authority provides guidance, supervision, and support within the AI regulatory sandbox.
- → exit report: The activities carried out in the AI regulatory sandbox are documented in an exit report.
- ← National competent authorities: National competent authorities supervise the AI regulatory sandbox to ensure compliance with relevant laws.
- → AI Office: The AI regulatory sandbox informs the AI Office about its establishment and operations.
- ← AI Office: The AI Office provides support and guidance to national competent authorities regarding the AI regulatory sandbox.
- ← AI Office: The AI Office encourages interaction in AI regulatory sandboxes.
- ← Commission: The Commission develops a dedicated interface for stakeholders to interact with AI regulatory sandboxes.
- → Article 62(1), point (c): The AI regulatory sandbox is governed by specific articles including Article 62(1), point (c).
- → personal data: The AI regulatory sandbox requires documentation on the lawful collection and processing of personal data for AI system development.
- ← Article 59: Article 59 lays down the rules for the further processing of personal data within the AI regulatory sandbox.
- → European Digital Innovation Hubs: The AI regulatory sandbox includes safeguards by directing providers to European Digital Innovation Hubs for support.
- → fundamental rights: The AI regulatory sandbox aims to improve the protection of fundamental rights during AI system development.
AI regulatory sandbox
A controlled environment established by a competent authority for the development and testing of AI systems under regulatory supervision.
- ← AI systems: AI systems require a regulatory sandbox for development and testing under oversight.
- ← Member States: Member States are responsible for establishing AI regulatory sandboxes to facilitate AI innovation at the national level.
- → innovative AI systems: The AI regulatory sandbox provides a controlled environment for the development and testing of innovative AI systems.
- → SMEs: The AI regulatory sandbox aims to enhance accessibility for SMEs to foster innovation.
- → Union law: The AI regulatory sandbox operates to ensure compliance with Union law.
- → national competent authorities: The AI regulatory sandbox should cooperate with national competent authorities to ensure effective supervision.
- ← common rules for AI regulatory sandboxes: Common rules are established to ensure uniform implementation of AI regulatory sandboxes.
- → European Digital Innovation Hubs: The AI regulatory sandbox may involve European Digital Innovation Hubs to support innovation.
- → Regulation (EU) 2016/679: The AI regulatory sandbox operates under the rules established by Regulation (EU) 2016/679.
- → Regulation (EU) 2018/1725: The AI regulatory sandbox operates under the rules established by Regulation (EU) 2018/1725.
- → Directive (EU) 2016/680: The AI regulatory sandbox operates under the rules established by Directive (EU) 2016/680.
- → personal data: The AI regulatory sandbox allows the use of personal data for developing AI systems under specified conditions.
- ← real-world testing plan: The real-world testing plan is necessary for conducting tests within the AI regulatory sandbox.
- ← sandbox plan: The sandbox plan outlines the conditions and requirements for activities in the AI regulatory sandbox.
- → AI literacy: The AI regulatory sandbox aims to improve AI literacy among providers and users.
- → 2 August 2026: The operational deadline for the AI regulatory sandboxes established by Member States.
- ← European Data Protection Supervisor: The European Data Protection Supervisor may establish an AI regulatory sandbox for Union institutions.
- → AI ecosystem: AI regulatory sandboxes are designed to foster innovation within the AI ecosystem.
- ← competent authority: The competent authority provides guidance, supervision, and support within the AI regulatory sandbox.
- → exit report: The activities carried out in the AI regulatory sandbox are documented in an exit report.
- ← National competent authorities: National competent authorities supervise the AI regulatory sandbox to ensure compliance with relevant laws.
- → AI Office: The AI regulatory sandbox informs the AI Office about its establishment and operations.
- ← AI Office: The AI Office provides support and guidance to national competent authorities regarding the AI regulatory sandbox.
- ← AI Office: The AI Office encourages interaction in AI regulatory sandboxes.
- ← Commission: The Commission develops a dedicated interface for stakeholders to interact with AI regulatory sandboxes.
- → Article 62(1), point (c): The AI regulatory sandbox is governed by specific articles including Article 62(1), point (c).
- → personal data: The AI regulatory sandbox requires documentation on the lawful collection and processing of personal data for AI system development.
- ← Article 59: Article 59 lays down the rules for the further processing of personal data within the AI regulatory sandbox.
- → European Digital Innovation Hubs: The AI regulatory sandbox includes safeguards by directing providers to European Digital Innovation Hubs for support.
- → fundamental rights: The AI regulatory sandbox aims to improve the protection of fundamental rights during AI system development.
AI regulatory sandbox
A framework established to allow for the testing of AI technologies in a controlled environment.
- ← AI systems: AI systems require a regulatory sandbox for development and testing under oversight.
- ← Member States: Member States are responsible for establishing AI regulatory sandboxes to facilitate AI innovation at the national level.
- → innovative AI systems: The AI regulatory sandbox provides a controlled environment for the development and testing of innovative AI systems.
- → SMEs: The AI regulatory sandbox aims to enhance accessibility for SMEs to foster innovation.
- → Union law: The AI regulatory sandbox operates to ensure compliance with Union law.
- → national competent authorities: The AI regulatory sandbox should cooperate with national competent authorities to ensure effective supervision.
- ← common rules for AI regulatory sandboxes: Common rules are established to ensure uniform implementation of AI regulatory sandboxes.
- → European Digital Innovation Hubs: The AI regulatory sandbox may involve European Digital Innovation Hubs to support innovation.
- → Regulation (EU) 2016/679: The AI regulatory sandbox operates under the rules established by Regulation (EU) 2016/679.
- → Regulation (EU) 2018/1725: The AI regulatory sandbox operates under the rules established by Regulation (EU) 2018/1725.
- → Directive (EU) 2016/680: The AI regulatory sandbox operates under the rules established by Directive (EU) 2016/680.
- → personal data: The AI regulatory sandbox allows the use of personal data for developing AI systems under specified conditions.
- ← real-world testing plan: The real-world testing plan is necessary for conducting tests within the AI regulatory sandbox.
- ← sandbox plan: The sandbox plan outlines the conditions and requirements for activities in the AI regulatory sandbox.
- → AI literacy: The AI regulatory sandbox aims to improve AI literacy among providers and users.
- → 2 August 2026: The operational deadline for the AI regulatory sandboxes established by Member States.
- ← European Data Protection Supervisor: The European Data Protection Supervisor may establish an AI regulatory sandbox for Union institutions.
- → AI ecosystem: AI regulatory sandboxes are designed to foster innovation within the AI ecosystem.
- ← competent authority: The competent authority provides guidance, supervision, and support within the AI regulatory sandbox.
- → exit report: The activities carried out in the AI regulatory sandbox are documented in an exit report.
- ← National competent authorities: National competent authorities supervise the AI regulatory sandbox to ensure compliance with relevant laws.
- → AI Office: The AI regulatory sandbox informs the AI Office about its establishment and operations.
- ← AI Office: The AI Office provides support and guidance to national competent authorities regarding the AI regulatory sandbox.
- ← AI Office: The AI Office encourages interaction in AI regulatory sandboxes.
- ← Commission: The Commission develops a dedicated interface for stakeholders to interact with AI regulatory sandboxes.
- → Article 62(1), point (c): The AI regulatory sandbox is governed by specific articles including Article 62(1), point (c).
- → personal data: The AI regulatory sandbox requires documentation on the lawful collection and processing of personal data for AI system development.
- ← Article 59: Article 59 lays down the rules for the further processing of personal data within the AI regulatory sandbox.
- → European Digital Innovation Hubs: The AI regulatory sandbox includes safeguards by directing providers to European Digital Innovation Hubs for support.
- → fundamental rights: The AI regulatory sandbox aims to improve the protection of fundamental rights during AI system development.
AI regulatory sandboxes
Controlled environments established by Member States for SMEs to test AI systems under regulatory oversight, ensuring compliance with legal standards.
- ← Member States: Member States provide AI regulatory sandboxes for SMEs to test their AI systems.
- → 2 August 2026: AI regulatory sandboxes must be operational by 2 August 2026.
- → Member States: The establishment of AI regulatory sandboxes affects the market by providing a controlled environment for AI innovation.
- → national competent authorities: National competent authorities are involved in the operation and supervision of AI regulatory sandboxes.
- → Union market: The establishment of AI regulatory sandboxes aims to facilitate and accelerate access to the Union market for AI systems.
- → AI Office: Decisions regarding the suspension of testing processes in AI regulatory sandboxes are communicated to the AI Office.
- ← European Commission: The European Commission lays down rules for the establishment and functioning of AI regulatory sandboxes.
- ← Article 58: Article 58 contains provisions regarding the detailed arrangements for AI regulatory sandboxes.
- → SMEs: AI regulatory sandboxes include safeguards to ensure free access for SMEs, including start-ups.
- → SMEs: AI regulatory sandboxes facilitate the participation of SMEs by simplifying application and administrative processes.
- → European Data Protection Supervisor: AI regulatory sandboxes may involve the European Data Protection Supervisor in their operations to ensure compliance with data protection regulations.
- → fundamental rights: AI regulatory sandboxes include safeguards to mitigate risks to fundamental rights and society.
- → accuracy: AI regulatory sandboxes assess the accuracy of AI systems as part of their benchmarking and testing processes.
- → robustness: AI regulatory sandboxes evaluate the robustness of AI systems to ensure they can handle various operational conditions.
- → cybersecurity: AI regulatory sandboxes assess cybersecurity measures to protect AI systems from potential threats.
- → Union or national law: The processing of personal data in AI regulatory sandboxes is based on specific Union or national laws.
- → personal data: AI regulatory sandboxes establish rules for the processing of personal data under specific conditions.
- ← Article 61: Article 61 acts in accordance with the provisions set for AI regulatory sandboxes by establishing consent requirements.
- ← Article 62: Article 62 outlines measures for providing SMEs access to AI regulatory sandboxes.
- → SMEs: The establishment of AI regulatory sandboxes is intended to benefit SMEs by providing them with priority access.
AI regulatory sandboxes
Regulatory frameworks that allow AI providers to test technologies in controlled environments, ensuring compliance and fostering innovation.
- ← Member States: Member States provide AI regulatory sandboxes for SMEs to test their AI systems.
- → 2 August 2026: AI regulatory sandboxes must be operational by 2 August 2026.
- → Member States: The establishment of AI regulatory sandboxes affects the market by providing a controlled environment for AI innovation.
- → national competent authorities: National competent authorities are involved in the operation and supervision of AI regulatory sandboxes.
- → Union market: The establishment of AI regulatory sandboxes aims to facilitate and accelerate access to the Union market for AI systems.
- → AI Office: Decisions regarding the suspension of testing processes in AI regulatory sandboxes are communicated to the AI Office.
- ← European Commission: The European Commission lays down rules for the establishment and functioning of AI regulatory sandboxes.
- ← Article 58: Article 58 contains provisions regarding the detailed arrangements for AI regulatory sandboxes.
- → SMEs: AI regulatory sandboxes include safeguards to ensure free access for SMEs, including start-ups.
- → SMEs: AI regulatory sandboxes facilitate the participation of SMEs by simplifying application and administrative processes.
- → European Data Protection Supervisor: AI regulatory sandboxes may involve the European Data Protection Supervisor in their operations to ensure compliance with data protection regulations.
- → fundamental rights: AI regulatory sandboxes include safeguards to mitigate risks to fundamental rights and society.
- → accuracy: AI regulatory sandboxes assess the accuracy of AI systems as part of their benchmarking and testing processes.
- → robustness: AI regulatory sandboxes evaluate the robustness of AI systems to ensure they can handle various operational conditions.
- → cybersecurity: AI regulatory sandboxes assess cybersecurity measures to protect AI systems from potential threats.
- → Union or national law: The processing of personal data in AI regulatory sandboxes is based on specific Union or national laws.
- → personal data: AI regulatory sandboxes establish rules for the processing of personal data under specific conditions.
- ← Article 61: Article 61 acts in accordance with the provisions set for AI regulatory sandboxes by establishing consent requirements.
- ← Article 62: Article 62 outlines measures for providing SMEs access to AI regulatory sandboxes.
- → SMEs: The establishment of AI regulatory sandboxes is intended to benefit SMEs by providing them with priority access.
AI system
An AI system that performs tasks requiring human intelligence, capable of learning and reasoning, and may be subject to regulations based on its risk classification and intended use.
- ← Regulation (EU) 2022/2065: The regulation lays down rules regarding the definition and characteristics of AI systems.
- → machine learning approaches: AI systems utilize machine learning approaches as part of their inference capabilities.
- → logic- and knowledge-based approaches: AI systems also incorporate logic- and knowledge-based approaches for inference.
- → Union: AI systems used in third countries can affect the market in the Union by processing data and providing outputs.
- ← Regulation 2024/1689: The regulation includes safeguards for the deployment of AI systems by Union institutions.
- → Regulation: AI systems must comply with the Regulation unless they are used for excluded purposes.
- → civilian purposes: AI systems intended for civilian purposes are subject to the Regulation.
- → law enforcement: AI systems intended for law enforcement are included under the Regulation's scope.
- → ethical principles: AI systems should be developed in alignment with ethical principles to ensure fairness and non-discrimination.
- ← Union values: AI systems that contradict Union values, such as manipulative practices, should be prohibited.
- → Directive 2005/29/EC: The AI system's prohibitions on manipulative practices are complementary to the provisions of Directive 2005/29/EC.
- ← biometric data: The regulation prohibits the use of biometric data for manipulative practices while allowing lawful categorization.
- ← social scoring: Social scoring by AI systems may lead to discriminatory outcomes, affecting market dynamics and inclusion.
- ← Regulation: The Regulation includes safeguards for AI systems that do not materially influence decision-making.
- → Regulation (EU) 2016/679: AI systems must process personal data in compliance with Regulation (EU) 2016/679 regarding data protection.
- → Directive (EU) 2016/680: AI systems must operate in accordance with Directive (EU) 2016/680 for data processing by authorities, particularly in law enforcement.
- → Regulation (EU) 2018/1725: AI systems must adhere to Regulation (EU) 2018/1725 concerning personal data processing by EU institutions.
- → EU database: AI systems must be registered in the EU database established under Regulation (EU) 2016/679.
- ← Regulation (EU) 2016/679: Regulation (EU) 2016/679 lays down rules for the assessment and registration of AI systems.
- ← biometric data: The classification of biometric data as high-risk affects the market for AI systems utilizing such data.
- ← data governance: Data governance establishes rules that must be followed for the compliance of AI systems.
- ← European health data space: The health data space allows for the training of AI algorithms using health data.
- → personal data: AI systems must process personal data in compliance with data protection principles.
- → Regulation (EU) 2016/679: AI systems must provide documentation to demonstrate compliance with GDPR.
- → Regulation (EU) 2018/1725: AI systems must comply with the documentation requirements set forth in this regulation.
- → Directive (EU) 2016/680: AI systems must adhere to the documentation requirements outlined in this directive.
- → cybersecurity: AI systems must comply with cybersecurity measures to ensure their resilience against risks.
- → high-risk AI system: AI systems that comply with obligations set out in regulations.
- ← model cards: Model cards are recommended documentation practices for AI systems to enhance transparency.
- ← data sheets: Data sheets are suggested as a means to provide essential information about datasets used in AI systems.
- ← free and open-source licence: Tools and services under this licence are not mandated to comply with certain regulatory requirements.
- → AI model: AI systems may include safeguards to ensure compliance with regulations regarding content generation.
- → deep fakes: AI systems that generate deep fakes must document and disclose the artificial nature of the content.
- → personal data: The AI system must include safeguards to protect personal data and ensure it is deleted when consent is withdrawn.
- ← Member States: Member States are encouraged to support and promote the development of AI solutions for beneficial outcomes.
- → provider: The provider develops or places the AI system on the market.
- → deployer: The deployer uses the AI system under its authority.
- ← importer: The importer places the AI system on the market.
- ← importer: The importer is responsible for placing AI systems on the market.
- ← distributor: The distributor makes AI systems available on the Union market.
- ← operator: The operator encompasses various roles involved in the handling of AI systems.
- → technical documentation: AI systems must have technical documentation detailing their intended use, training, testing, and validation processes.
- ← substantial modification: Substantial modifications affect the compliance of AI systems with initial assessment requirements.
- ← CE marking: CE marking lays down rules for indicating conformity of AI systems with regulatory requirements.
- ← post-market monitoring system: The post-market monitoring system requires documentation of user experience for corrective actions.
- ← training data: Training data is a data set used for training AI systems.
- ← validation data: Validation data is a data set used for evaluating AI systems.
- → natural persons: The regulation lays down rules for the use of AI systems in making risk assessments of natural persons.
- ← facial recognition databases: The regulation proposes restrictions on the use of AI systems that create or expand facial recognition databases.
- ← Annex III: Annex III lays down rules for the classification of AI systems as high-risk based on their potential impact on health, safety, and fundamental rights.
- → fundamental rights: The deployment of AI systems can impact fundamental rights, leading to potential harm or adverse effects.
- → Union law: The deployment of AI systems must comply with existing Union law that provides measures for redress and risk minimization.
- ← vulnerable position: Individuals in a vulnerable position may be disproportionately affected by the outcomes produced by AI systems.
- ← Article 8: Article 8 lays down compliance requirements for high-risk AI systems.
- ← Article 9: Article 9 refers to the risk management system that must be considered for compliance of high-risk AI systems.
- → Union harmonisation legislation: AI systems must comply with the requirements of Union harmonisation legislation.
- → OJ L: The AI system must disclose its nature when generating or manipulating content published in the Official Journal.
- ← provider or prospective provider: Providers must provide relevant instructions for the use of the AI system during testing.
- → Article 13: The AI system is governed by the instructions outlined in Article 13.
- → Article 61: The AI system's testing requires informed consent as specified in Article 61.
- ← market surveillance authorities: Market surveillance authorities regulate high-risk AI systems, impacting their market presence.
- → personal data: The AI system must ensure the deletion of personal data after testing.
- ← market surveillance authority: The market surveillance authority proposes measures to prohibit or restrict the AI system's availability on the market if non-compliance is detected.
- → Article 5: The AI system must comply with the prohibitions outlined in Article 5.
- → Chapter III, Section 2: High-risk AI systems must comply with the requirements set out in Chapter III, Section 2, including validation and testing procedures.
- → Articles 40 and 41: The AI system must adhere to harmonised standards or common specifications as per Articles 40 and 41.
- → Article 50: The AI system must comply with the requirements outlined in Article 50.
- ← Article 5: Article 5 prohibits certain AI practices that require documentation for compliance.
- ← Article 40: Article 40 lays down rules regarding the presumption of conformity for AI systems.
- ← Article 41: Article 41 lays down additional rules regarding the presumption of conformity for AI systems.
- ← Article 50: Article 50 addresses non-compliance issues related to AI systems.
- ← market surveillance authority: The market surveillance authority evaluates AI systems classified as non-high-risk to determine if they are high-risk.
- → Article 6(3): AI systems are classified as high-risk or non-high-risk based on the conditions set out in Article 6(3).
- ← provider: The provider must ensure that the AI system complies with the requirements laid down in the regulation.
- → Article 99: Article 99 lays down rules regarding fines for non-compliance of AI systems.
- → Article 79: Article 79 requires documentation of corrective actions for AI systems.
- → administrative fine: The purpose of the AI system is considered when determining the amount of administrative fines.
- ← European Data Protection Supervisor: The European Data Protection Supervisor oversees compliance related to AI systems.
- → Article 14: The AI system requires documentation regarding human oversight measures as specified in Article 14.
- → Article 13(3), point (d): The AI system requires documentation on technical measures for output interpretation as outlined in Article 13(3), point (d).
- → Article 9: The AI system must have a risk management system as outlined in Article 9.
- ← validation and testing procedures: The validation and testing procedures lay down rules for the performance and compliance of the AI system.
- → cybersecurity measures: The AI system includes cybersecurity measures as safeguards against potential threats.
- → Article 9: The AI system must have a detailed risk management system as outlined in Article 9.
- → Article 47: The AI system requires an EU declaration of conformity as specified in Article 47.
- → Article 72: The AI system must have a system in place to evaluate its performance in the post-market phase as per Article 72.
- ← Article 47: Article 47 lays down rules for the conformity declaration of the AI system.
- ← quality management system: The quality management system lays down rules for the design, development, and testing of AI systems.
- ← Article 72: The design and development process of the AI system must act in accordance with Article 72.
- ← notified body: The notified body assesses the conformity of the AI system with the requirements set out in Chapter III, Section 2.
- → parameters: The AI system has relevant parameters that may be assessed by the notified body.
- → Union technical documentation assessment certificate: The AI system must conform to requirements to receive the assessment certificate.
- → quality data: The AI system requires quality data for training to ensure compliance.
- → Article 49(2): The AI system must provide specific information as outlined in Article 49(2).
- → Article 6(3): The AI system's classification as not-high-risk is based on conditions specified in Article 6(3).
- → Annex III: The AI system may be classified as high-risk based on criteria listed in Annex III.
- ← notified body: The notified body issues certificates for AI systems, ensuring compliance with regulations.
- ← Member States: Member States regulate the placement of AI systems on the market within the EU.
- → Article 49(3): The AI system requires documentation to be submitted by its deployer as per Article 49(3).
- → Article 27: The AI system must undergo a fundamental rights impact assessment as specified in Article 27.
- → Article 35 of Regulation (EU) 2016/679: The AI system must comply with data protection impact assessment requirements in Article 35.
- → Article 27 of Directive (EU) 2016/680: The AI system may need to adhere to additional data protection assessments as per Article 27 of Directive (EU) 2016/680.
- → EU database: The AI system's information is submitted to the EU database by its provider.
AI systems
AI systems are technological frameworks designed to perform tasks requiring human-like intelligence, subject to regulations ensuring their safety, compliance, and ethical use across various sectors, including high-risk applications.
- ← Regulation: The Regulation establishes rules for the development, marketing, and use of AI systems to ensure safety and trustworthiness, particularly in military and national security contexts.
- → Charter of Fundamental Rights of the European Union: AI systems must be developed and used in accordance with the fundamental rights obligations outlined in the Charter.
- ← 2024/1689: The regulation lays down uniform obligations for operators regarding the use of AI systems.
- ← Regulation (EU) 2019/1020: The regulation addresses the impact of AI systems on consumers and other persons.
- → personal data: AI systems must comply with documentation requirements related to the processing of personal data.
- → deployer: The use of AI systems by deployers may affect persons other than the deployer.
- → fundamental rights: AI systems are designed to enhance the protection of fundamental rights.
- → health and safety: AI systems aim to improve health and safety regulations.
- ← AI literacy: AI literacy proposes equipping users with the necessary knowledge to engage with AI systems effectively.
- → civilian purposes: AI systems can be used for civilian purposes, which are non-military in nature.
- → law enforcement: AI systems may also be applied in law enforcement activities.
- → public security: AI systems can be utilized to enhance public security.
- → significant harm: AI systems are discussed in the context of potentially causing significant harm to individuals.
- → extreme poverty: AI systems can exploit individuals living in extreme poverty.
- → ethnic or religious minorities: AI systems can exploit ethnic or religious minorities.
- → biometric data: AI systems utilize biometric data for identification and to infer emotions or intentions.
- ← natural persons: Natural persons should not be judged based on AI systems' predictions without human assessment.
- → facial recognition databases: The use of AI systems to create or expand facial recognition databases through untargeted scraping should be prohibited.
- → risk analytics: AI systems can use risk analytics that do not involve profiling individuals.
- → Union law: AI systems must comply with Union law, including data protection and non-discrimination laws.
- ← Union law: Union law includes safeguards to protect individuals from the intrusive nature of AI systems.
- → fundamental rights: AI systems can adversely impact fundamental rights, particularly in data protection and privacy, which is critical for their classification as high risk.
- ← Union harmonisation legislation: The legislation establishes rules to ensure that AI systems do not compromise safety and compliance in the market.
- ← health sector: The health sector necessitates reliable AI systems that must be documented to ensure safety and effectiveness.
- → education: AI systems are deployed in education to enhance digital skills and competences.
- → learning outcomes: AI systems evaluate learning outcomes and influence educational paths.
- ← media literacy: Media literacy is a parameter that AI systems aim to promote in education.
- ← critical thinking: Critical thinking is a competence that AI systems help develop in learners.
- → natural persons: AI systems determine the granting or denial of benefits to natural persons.
- → law enforcement authorities: AI systems are intended for use by law enforcement authorities in critical decision-making situations.
- → high-quality data: AI systems require high-quality data to function effectively and avoid discriminatory outcomes.
- → transparency: AI systems should be transparent to ensure accountability and public trust.
- → effective remedy: The decisions made by AI systems can affect the right to an effective remedy.
- → fair trial: The use of AI systems may compromise the right to a fair trial.
- → presumption of innocence: AI systems could undermine the presumption of innocence in legal proceedings.
- → natural person: AI systems assess the risk of natural persons becoming victims or offenders.
- ← Union anti-money laundering law: AI systems used for administrative tasks by tax and customs authorities are excluded from high-risk classification.
- → natural persons: AI systems used in migration and border control management can significantly impact the treatment of vulnerable natural persons in the market.
- → Regulation (EC) No 810/2009: AI systems in migration and border control must comply with the procedural requirements set by Regulation (EC) No 810/2009.
- ← fundamental rights: The accuracy and transparency of AI systems aim to improve the respect for fundamental rights of affected persons.
- → UN Convention relating to the Status of Refugees: AI systems in migration and asylum must comply with the obligations set by the UN Convention relating to the Status of Refugees.
- → Regulation (EU) 2024/900: AI systems intended to influence elections are classified as high-risk under Regulation (EU) 2024/900.
- → personal data: The classification of AI systems as high-risk does not imply lawful use under personal data protection laws.
- ← Regulation 2024/1689: Regulation 2024/1689 addresses the risks associated with AI systems in the market.
- ← risk-management system: The risk-management system aims to improve the safety and effectiveness of AI systems.
- ← general-purpose AI models: General-purpose AI models are integrated into AI systems along with additional components.
- → Regulation (EU) 2022/2065: AI systems must comply with the obligations set forth in Regulation (EU) 2022/2065 regarding the detection and disclosure of content.
- → natural persons: AI systems are intended to interact with natural persons, necessitating transparency obligations.
- → biometric data: AI systems may process biometric data to identify or infer emotions or intentions of natural persons.
- → synthetic content: AI systems generate synthetic content that is hard to distinguish from authentic content.
- → watermarks: AI systems are required to embed technical solutions like watermarks to indicate content origin.
- → metadata identifications: AI systems must utilize metadata identifications to prove content authenticity.
- → cryptographic methods: AI systems should implement cryptographic methods for content provenance.
- → logging methods: AI systems are expected to use logging methods to track content generation.
- → fingerprints: AI systems may use fingerprints to trace the origin of generated content.
- → general-purpose AI models: AI systems can include general-purpose AI models for content generation.
- ← downstream provider: Downstream providers must comply with obligations related to AI systems.
- → AI regulatory sandbox: AI systems require a regulatory sandbox for development and testing under oversight.
- ← Regulation 2024/1689: Regulation 2024/1689 lays down harmonized rules for the labeling of content generated by AI systems and their placement on the market in the Union.
- → Regulation (EU) 2019/1020: AI systems may be regulated under this regulation if they present risks.
- ← general-purpose AI models: General-purpose AI models serve as the basis for specific AI systems, influencing their design and functionality.
- ← Regulation (EU) 2023/988: Regulation (EU) 2023/988 acts as a safety net for AI systems that are not classified as high-risk.
- ← Union’s Ethics Guidelines for Trustworthy AI: The guidelines lay down rules for the ethical development and deployment of AI systems.
- ← stakeholders: Stakeholders are involved in ensuring that AI systems are developed with safeguards for inclusivity and accessibility.
- ← Regulation (EU) 2024/1689: The regulation lays down rules for the application of AI systems in relation to national security.
- ← Union law: Union law lays down rules for the development and deployment of AI systems.
- ← Member States: Member States may propose laws that are more favorable to workers regarding AI systems.
- ← AI literacy: AI literacy aims to improve the informed deployment of AI systems.
- ← testing in real-world conditions: Defines the process for testing AI systems in real-world conditions.
- ← Prohibited AI practices: Defines the rules and restrictions regarding the use of AI systems that could cause harm.
- ← Article 7: Article 7 lays down rules for assessing high-risk AI systems based on specific criteria.
- ← Commission: The Commission aims to improve the resource performance of AI systems through standardisation requests.
- ← notified body: Notified bodies assess and certify AI systems based on conformity assessment procedures.
- ← technical solutions: Technical solutions aim to improve the effectiveness and reliability of AI systems.
- ← market surveillance authority: The market surveillance authority evaluates and monitors AI systems in accordance with Regulation (EU) 2019/1020.
- ← Article 79: Article 79 lays down rules for the evaluation of AI systems to ensure compliance.
- → Directive (EU) 2016/680: AI systems are intended to be used in compliance with the rules laid down in Directive (EU) 2016/680.
- → competent public authorities: AI systems are utilized by competent public authorities for various assessments, including risk evaluations and profiling.
- → competent public authorities: AI systems are intended to be used by or on behalf of competent public authorities.
- → judicial authority: AI systems assist judicial authorities in researching and interpreting facts and law.
- → election or referendum: AI systems are intended to influence the outcome of elections or referenda.
- ← notified body: The notified body assesses the AI systems during audits and compliance checks.
AI systems for credit evaluation
AI systems used to evaluate the credit score or creditworthiness of natural persons, classified as high-risk due to their impact on access to financial resources.
- → Union law: AI systems for credit evaluation are governed by Union law regarding their classification as high-risk.
AI systems for creditworthiness evaluation
AI systems intended to evaluate the creditworthiness of natural persons or establish their credit score.
- → natural persons: These AI systems assess the creditworthiness of individuals.
AI systems for detecting financial fraud
AI systems designed specifically to identify and prevent financial fraud.
AI systems for education assessment
AI systems intended to assess the appropriate level of education that an individual will receive or access within educational and vocational training institutions.
AI systems for emergency call evaluation
AI systems used to assess and classify emergency calls and prioritize dispatching emergency services.
AI systems for health and life insurance
AI systems intended for risk assessment and pricing in health and life insurance, which can significantly impact individuals' livelihoods.
- → Union law: AI systems for health and life insurance are also subject to Union law, which addresses their potential risks.
AI systems for monitoring prohibited behaviour
AI systems used for monitoring and detecting prohibited behaviour of students during tests in educational and vocational training institutions.
AI systems for public services evaluation
AI systems used by public authorities to evaluate the eligibility of natural persons for essential public assistance benefits and services.
- → natural persons: These AI systems evaluate individuals' eligibility for public assistance benefits.
AI systems for recruitment
AI systems intended for the recruitment or selection of natural persons, including placing job advertisements and evaluating candidates.
- → natural persons: These AI systems are used to recruit and select individuals for job positions.
AI systems for remote biometric identification
AI systems designed for the remote identification of individuals based on biometric data, which can lead to biased results and discriminatory effects.
- → law enforcement: The use of AI systems for biometric identification impacts the market for law enforcement activities.
- ← OJ L, 12.7.2024: The regulation concerning AI systems for biometric identification was published on this date.
AI systems for risk assessment and pricing
AI systems intended for evaluating risks and determining pricing in life and health insurance for natural persons.
- → Law enforcement authorities: These AI systems are intended to assist law enforcement authorities in assessing risks related to natural persons.
AI systems for risk assessment in insurance
AI systems used for risk assessment and pricing in relation to natural persons in life and health insurance.
- → natural persons: These AI systems are used for assessing risks related to individuals in insurance contexts.
AI systems for social scoring
AI systems that evaluate or classify natural persons or groups based on multiple data points related to their social behavior and personal characteristics.
- → natural persons: AI systems for social scoring evaluate natural persons, potentially leading to discriminatory outcomes.
- → law enforcement: These AI systems may be used in the context of law enforcement, impacting rights and freedoms.
- ← discriminatory outcomes: The potential for discriminatory outcomes necessitates safeguards against unacceptable scoring practices.
AI value chain
The series of processes and parties involved in the development and deployment of AI systems.
- → high-risk AI systems: The AI value chain includes multiple parties that supply components and services for high-risk AI systems.
AI-enabled manipulative techniques
Techniques that use AI to persuade individuals into unwanted behaviors or decisions, impairing their autonomy and decision-making.
alternative dispute resolution bodies
Institutions that facilitate the resolution of disputes outside of the court system.
- ← high-risk AI systems: High-risk AI systems may also be used by alternative dispute resolution bodies for legal proceedings.
Annex I
A section of the regulation listing Union harmonisation legislation relevant to AI systems and covering specific certification requirements.
- ← Regulation: The regulation includes safeguards related to high-risk AI systems as outlined in Annex I.
- ← High-Risk AI Systems: Annex I lists the legislation that safeguards the classification of high-risk AI systems.
- → product manufacturers: Annex I includes provisions that allow manufacturers to opt out from third-party conformity assessments.
- ← Certificates: Certificates for AI systems covered by Annex I have specific validity periods.
- ← high-risk AI systems: High-risk AI systems are covered under the Union harmonisation legislation listed in Annex I.
Annex I
Annex I lists the Union harmonisation legislation applicable to high-risk AI systems and relevant for market surveillance.
- ← Regulation: The regulation includes safeguards related to high-risk AI systems as outlined in Annex I.
- ← High-Risk AI Systems: Annex I lists the legislation that safeguards the classification of high-risk AI systems.
- → product manufacturers: Annex I includes provisions that allow manufacturers to opt out from third-party conformity assessments.
- ← Certificates: Certificates for AI systems covered by Annex I have specific validity periods.
- ← high-risk AI systems: High-risk AI systems are covered under the Union harmonisation legislation listed in Annex I.
Annex II
A section of the regulation that outlines specific offences punishable by custodial sentences or detention orders.
- → law enforcement: The offences listed in Annex II affect the operations and regulations of law enforcement agencies.
Annex III
Annex III specifies categories and compliance requirements for high-risk AI systems, including those subject to specific reporting obligations and regulatory oversight.
- ← High-Risk AI Systems: Annex III includes additional AI systems that may be classified as high-risk.
- → AI system: Annex III lays down rules for the classification of AI systems as high-risk based on their potential impact on health, safety, and fundamental rights.
- → Regulation: Annex III includes conditions that safeguard health, safety, and fundamental rights in relation to AI systems.
- ← Article 7: Article 7 empowers the Commission to amend Annex III regarding high-risk AI systems.
- ← Article 97: Article 97 empowers the Commission to amend the list in Annex III by removing high-risk AI systems.
- ← High-risk AI systems: High-risk AI systems must adhere to the logging capabilities specified in Annex III.
- ← high-risk AI systems: High-risk AI systems are defined and regulated according to the guidelines set forth in Annex III.
- ← high-risk AI systems: High-risk AI systems are defined and categorized in Annex III, which outlines specific regulations and additional requirements.
- → high-risk AI systems: Annex III lists the high-risk AI systems that must comply with specific requirements.
- ← high-risk AI system: Annex III categorizes high-risk AI systems that must follow specific procedures.
- ← Commission: The Commission amends regulations concerning high-risk AI systems as specified in Annex III.
- ← Certificates: Certificates for AI systems covered by Annex III have specific validity periods.
- → EU database: Annex III includes safeguards for the registration of high-risk AI systems in the EU database.
- ← EU database for high-risk AI systems: The EU database contains information concerning high-risk AI systems as referred to in Annex III.
- ← Regulation (EU) 2019/1020: Regulation (EU) 2019/1020 includes Annex III, which lists high-risk AI systems.
- ← high-risk AI systems: Annex III provides the parameters and criteria for classifying AI systems as high-risk.
- ← Article 5: Article 5 lays down the list of prohibited AI practices which is referenced in Annex III.
- ← Regulation: The Regulation includes a list of AI systems in Annex III that may require additional scrutiny.
- ← AI system: The AI system may be classified as high-risk based on criteria listed in Annex III.
Annex III
Annex III outlines the specific conditions under which AI systems are classified as high-risk and their associated requirements.
- ← High-Risk AI Systems: Annex III includes additional AI systems that may be classified as high-risk.
- → AI system: Annex III lays down rules for the classification of AI systems as high-risk based on their potential impact on health, safety, and fundamental rights.
- → Regulation: Annex III includes conditions that safeguard health, safety, and fundamental rights in relation to AI systems.
- ← Article 7: Article 7 empowers the Commission to amend Annex III regarding high-risk AI systems.
- ← Article 97: Article 97 empowers the Commission to amend the list in Annex III by removing high-risk AI systems.
- ← High-risk AI systems: High-risk AI systems must adhere to the logging capabilities specified in Annex III.
- ← high-risk AI systems: High-risk AI systems are defined and regulated according to the guidelines set forth in Annex III.
- ← high-risk AI systems: High-risk AI systems are defined and categorized in Annex III, which outlines specific regulations and additional requirements.
- → high-risk AI systems: Annex III lists the high-risk AI systems that must comply with specific requirements.
- ← high-risk AI system: Annex III categorizes high-risk AI systems that must follow specific procedures.
- ← Commission: The Commission amends regulations concerning high-risk AI systems as specified in Annex III.
- ← Certificates: Certificates for AI systems covered by Annex III have specific validity periods.
- → EU database: Annex III includes safeguards for the registration of high-risk AI systems in the EU database.
- ← EU database for high-risk AI systems: The EU database contains information concerning high-risk AI systems as referred to in Annex III.
- ← Regulation (EU) 2019/1020: Regulation (EU) 2019/1020 includes Annex III, which lists high-risk AI systems.
- ← high-risk AI systems: Annex III provides the parameters and criteria for classifying AI systems as high-risk.
- ← Article 5: Article 5 lays down the list of prohibited AI practices which is referenced in Annex III.
- ← Regulation: The Regulation includes a list of AI systems in Annex III that may require additional scrutiny.
- ← AI system: The AI system may be classified as high-risk based on criteria listed in Annex III.
Annex III
This annex provides details on high-risk AI systems, including use-cases, compliance requirements, and classifications.
- ← High-Risk AI Systems: Annex III includes additional AI systems that may be classified as high-risk.
- → AI system: Annex III lays down rules for the classification of AI systems as high-risk based on their potential impact on health, safety, and fundamental rights.
- → Regulation: Annex III includes conditions that safeguard health, safety, and fundamental rights in relation to AI systems.
- ← Article 7: Article 7 empowers the Commission to amend Annex III regarding high-risk AI systems.
- ← Article 97: Article 97 empowers the Commission to amend the list in Annex III by removing high-risk AI systems.
- ← High-risk AI systems: High-risk AI systems must adhere to the logging capabilities specified in Annex III.
- ← high-risk AI systems: High-risk AI systems are defined and regulated according to the guidelines set forth in Annex III.
- ← high-risk AI systems: High-risk AI systems are defined and categorized in Annex III, which outlines specific regulations and additional requirements.
- → high-risk AI systems: Annex III lists the high-risk AI systems that must comply with specific requirements.
- ← high-risk AI system: Annex III categorizes high-risk AI systems that must follow specific procedures.
- ← Commission: The Commission amends regulations concerning high-risk AI systems as specified in Annex III.
- ← Certificates: Certificates for AI systems covered by Annex III have specific validity periods.
- → EU database: Annex III includes safeguards for the registration of high-risk AI systems in the EU database.
- ← EU database for high-risk AI systems: The EU database contains information concerning high-risk AI systems as referred to in Annex III.
- ← Regulation (EU) 2019/1020: Regulation (EU) 2019/1020 includes Annex III, which lists high-risk AI systems.
- ← high-risk AI systems: Annex III provides the parameters and criteria for classifying AI systems as high-risk.
- ← Article 5: Article 5 lays down the list of prohibited AI practices which is referenced in Annex III.
- ← Regulation: The Regulation includes a list of AI systems in Annex III that may require additional scrutiny.
- ← AI system: The AI system may be classified as high-risk based on criteria listed in Annex III.
Annex III
This directive specifies the types of high-risk AI systems and outlines the registration requirements for their deployment.
- ← High-Risk AI Systems: Annex III includes additional AI systems that may be classified as high-risk.
- → AI system: Annex III lays down rules for the classification of AI systems as high-risk based on their potential impact on health, safety, and fundamental rights.
- → Regulation: Annex III includes conditions that safeguard health, safety, and fundamental rights in relation to AI systems.
- ← Article 7: Article 7 empowers the Commission to amend Annex III regarding high-risk AI systems.
- ← Article 97: Article 97 empowers the Commission to amend the list in Annex III by removing high-risk AI systems.
- ← High-risk AI systems: High-risk AI systems must adhere to the logging capabilities specified in Annex III.
- ← high-risk AI systems: High-risk AI systems are defined and regulated according to the guidelines set forth in Annex III.
- ← high-risk AI systems: High-risk AI systems are defined and categorized in Annex III, which outlines specific regulations and additional requirements.
- → high-risk AI systems: Annex III lists the high-risk AI systems that must comply with specific requirements.
- ← high-risk AI system: Annex III categorizes high-risk AI systems that must follow specific procedures.
- ← Commission: The Commission amends regulations concerning high-risk AI systems as specified in Annex III.
- ← Certificates: Certificates for AI systems covered by Annex III have specific validity periods.
- → EU database: Annex III includes safeguards for the registration of high-risk AI systems in the EU database.
- ← EU database for high-risk AI systems: The EU database contains information concerning high-risk AI systems as referred to in Annex III.
- ← Regulation (EU) 2019/1020: Regulation (EU) 2019/1020 includes Annex III, which lists high-risk AI systems.
- ← high-risk AI systems: Annex III provides the parameters and criteria for classifying AI systems as high-risk.
- ← Article 5: Article 5 lays down the list of prohibited AI practices which is referenced in Annex III.
- ← Regulation: The Regulation includes a list of AI systems in Annex III that may require additional scrutiny.
- ← AI system: The AI system may be classified as high-risk based on criteria listed in Annex III.
Annex III
A section of the regulation that lists specific high-risk AI systems in areas such as law enforcement and migration.
- ← High-Risk AI Systems: Annex III includes additional AI systems that may be classified as high-risk.
- → AI system: Annex III lays down rules for the classification of AI systems as high-risk based on their potential impact on health, safety, and fundamental rights.
- → Regulation: Annex III includes conditions that safeguard health, safety, and fundamental rights in relation to AI systems.
- ← Article 7: Article 7 empowers the Commission to amend Annex III regarding high-risk AI systems.
- ← Article 97: Article 97 empowers the Commission to amend the list in Annex III by removing high-risk AI systems.
- ← High-risk AI systems: High-risk AI systems must adhere to the logging capabilities specified in Annex III.
- ← high-risk AI systems: High-risk AI systems are defined and regulated according to the guidelines set forth in Annex III.
- ← high-risk AI systems: High-risk AI systems are defined and categorized in Annex III, which outlines specific regulations and additional requirements.
- → high-risk AI systems: Annex III lists the high-risk AI systems that must comply with specific requirements.
- ← high-risk AI system: Annex III categorizes high-risk AI systems that must follow specific procedures.
- ← Commission: The Commission amends regulations concerning high-risk AI systems as specified in Annex III.
- ← Certificates: Certificates for AI systems covered by Annex III have specific validity periods.
- → EU database: Annex III includes safeguards for the registration of high-risk AI systems in the EU database.
- ← EU database for high-risk AI systems: The EU database contains information concerning high-risk AI systems as referred to in Annex III.
- ← Regulation (EU) 2019/1020: Regulation (EU) 2019/1020 includes Annex III, which lists high-risk AI systems.
- ← high-risk AI systems: Annex III provides the parameters and criteria for classifying AI systems as high-risk.
- ← Article 5: Article 5 lays down the list of prohibited AI practices which is referenced in Annex III.
- ← Regulation: The Regulation includes a list of AI systems in Annex III that may require additional scrutiny.
- ← AI system: The AI system may be classified as high-risk based on criteria listed in Annex III.
Annex IV
Annex IV outlines the minimum elements required in the technical documentation for high-risk AI systems.
- ← technical documentation: The technical documentation must include elements specified in Annex IV to ensure compliance.
- ← Commission: The Commission proposes to establish a simplified technical documentation form as outlined in Annex IV.
- ← high-risk AI system: High-risk AI systems require a single set of technical documentation as specified in Annex IV.
- ← post-market monitoring plan: The post-market monitoring plan is part of the technical documentation outlined in Annex IV.
- ← market surveillance authorities: Market surveillance authorities require access to technical documentation as outlined in Annex IV.
Annex IV
This annex specifies the technical documentation requirements for high-risk AI systems, including simplified provisions for SMEs.
- ← technical documentation: The technical documentation must include elements specified in Annex IV to ensure compliance.
- ← Commission: The Commission proposes to establish a simplified technical documentation form as outlined in Annex IV.
- ← high-risk AI system: High-risk AI systems require a single set of technical documentation as specified in Annex IV.
- ← post-market monitoring plan: The post-market monitoring plan is part of the technical documentation outlined in Annex IV.
- ← market surveillance authorities: Market surveillance authorities require access to technical documentation as outlined in Annex IV.
Annex IX
A directive that includes additional points relevant to the registration of high-risk AI systems.
- ← real-world testing plan: The real-world testing plan must include information specified in Annex IX.
- ← Article 60: Article 60 includes safeguards regarding the registration of high-risk AI systems as detailed in Annex IX.
Annex IX
An annex specifying the information required for the registration of high-risk AI systems.
- ← real-world testing plan: The real-world testing plan must include information specified in Annex IX.
- ← Article 60: Article 60 includes safeguards regarding the registration of high-risk AI systems as detailed in Annex IX.
Annex V
Annex V outlines the information that must be included in the EU declaration of conformity.
- ← EU declaration of conformity: The EU declaration of conformity must contain the information specified in Annex V.
- ← Article 97: Article 97 allows for amendments to Annex V regarding the EU declaration of conformity.
Annex V
Annex V contains information related to the EU declaration of conformity for high-risk AI systems.
- ← EU declaration of conformity: The EU declaration of conformity must contain the information specified in Annex V.
- ← Article 97: Article 97 allows for amendments to Annex V regarding the EU declaration of conformity.
Annex VI
An annex describing internal control procedures for conformity assessment.
- → conformity assessment: Annex VI outlines the internal control documentation required for conformity assessment.
- ← high-risk AI system: Annex VI describes the internal control conformity assessment procedure for high-risk AI systems.
Annex VI
Annex that discusses internal control measures for conformity assessment procedures.
- → conformity assessment: Annex VI outlines the internal control documentation required for conformity assessment.
- ← high-risk AI system: Annex VI describes the internal control conformity assessment procedure for high-risk AI systems.
Annex VII
An annex outlining conformity assessment procedures specifically for high-risk AI systems.
- → conformity assessment procedures: Annex VII details the conformity assessment procedures for high-risk AI systems.
- ← high-risk AI system: High-risk AI systems must comply with the conformity assessment procedures outlined in Annex VII.
- ← notified body: Notified bodies must issue technical documentation assessment certificates and quality management system approvals as per Annex VII.
Annex VII
Annex that outlines the conformity assessment procedure for AI systems.
- → conformity assessment procedures: Annex VII details the conformity assessment procedures for high-risk AI systems.
- ← high-risk AI system: High-risk AI systems must comply with the conformity assessment procedures outlined in Annex VII.
- ← notified body: Notified bodies must issue technical documentation assessment certificates and quality management system approvals as per Annex VII.
Annex VII
A section of regulatory documentation that specifies requirements for technical documentation assessment and quality management system approvals.
- → conformity assessment procedures: Annex VII details the conformity assessment procedures for high-risk AI systems.
- ← high-risk AI system: High-risk AI systems must comply with the conformity assessment procedures outlined in Annex VII.
- ← notified body: Notified bodies must issue technical documentation assessment certificates and quality management system approvals as per Annex VII.
Annex VIII
A directive that specifies the information required for the registration of high-risk AI systems.
- → EU database: Annex VIII requires specific documentation for the registration of high-risk AI systems in the EU database.
- ← EU database for high-risk AI systems: The EU database requires data listed in Annex VIII to be entered by the provider or authorized representative.
Annex VIII
An annex that lists data to be entered into the EU database concerning high-risk AI systems.
- → EU database: Annex VIII requires specific documentation for the registration of high-risk AI systems in the EU database.
- ← EU database for high-risk AI systems: The EU database requires data listed in Annex VIII to be entered by the provider or authorized representative.
Annex VIII
A section of the regulation that lists the data to be entered into the EU database.
- → EU database: Annex VIII requires specific documentation for the registration of high-risk AI systems in the EU database.
- ← EU database for high-risk AI systems: The EU database requires data listed in Annex VIII to be entered by the provider or authorized representative.
Annex XI
A section of the regulation that outlines minimum information requirements for technical documentation of AI models.
- ← general-purpose AI models: Annex XI outlines the minimum information requirements for the technical documentation.
- ← Regulation 2024/1689: Regulation 2024/1689 includes directives related to compliance as outlined in Annex XI.
- ← Commission: The Commission requires that technical documentation specified in Annex XI be fulfilled by providers.
Annex XI
An annex detailing compliance obligations and technical requirements for AI model providers.
- ← general-purpose AI models: Annex XI outlines the minimum information requirements for the technical documentation.
- ← Regulation 2024/1689: Regulation 2024/1689 includes directives related to compliance as outlined in Annex XI.
- ← Commission: The Commission requires that technical documentation specified in Annex XI be fulfilled by providers.
Annex XII
A section of the regulation that specifies elements to be included in the documentation for AI systems.
- ← general-purpose AI models: Annex XII specifies elements to be included in the documentation for AI systems.
- ← Regulation 2024/1689: The regulation empowers the Commission to amend Annex XII in response to technological developments.
Annex XII
An annex that may be amended to reflect evolving technological developments.
- ← general-purpose AI models: Annex XII specifies elements to be included in the documentation for AI systems.
- ← Regulation 2024/1689: The regulation empowers the Commission to amend Annex XII in response to technological developments.
Annex XIII
A document that contains criteria for evaluating the capabilities and impact of AI models.
- → high impact capabilities: Annex XIII includes criteria that safeguard the evaluation of high impact capabilities of AI models.
- ← Commission: The Commission is empowered to amend Annex XIII to update the criteria for systemic risks.
- ← general-purpose AI model: The designation of a general-purpose AI model as presenting systemic risks is based on criteria set out in Annex XIII.
Annex XIII
A section of the regulation that outlines the criteria for designating general-purpose AI models as presenting systemic risks.
- → high impact capabilities: Annex XIII includes criteria that safeguard the evaluation of high impact capabilities of AI models.
- ← Commission: The Commission is empowered to amend Annex XIII to update the criteria for systemic risks.
- ← general-purpose AI model: The designation of a general-purpose AI model as presenting systemic risks is based on criteria set out in Annex XIII.
Annexes VI and VII
Annexes that are subject to amendment by the Commission in light of technical progress.
- ← Commission: The Commission is empowered to amend Annexes VI and VII.
annual reports
Reports submitted by Member States to the Commission regarding the use of biometric identification systems.
- ← Commission: The Commission publishes annual reports based on the aggregated data from Member States regarding biometric identification systems.
Article 10
An article within Directive (EU) 2016/680 that outlines specific rules regarding the processing of biometric data.
- ← Directive (EU) 2016/680: Directive (EU) 2016/680 includes Article 10, which specifies rules for biometric data processing.
Article 10 of Directive (EU) 2016/680
An article that allows the processing of biometric data only where strictly necessary and subject to appropriate safeguards.
Article 10(4)
An article within a regulation that outlines specific requirements for AI systems.
- ← high-risk AI systems: High-risk AI systems are presumed to comply with the requirements laid down in Article 10(4).
Article 100
A specific article within the regulation that addresses administrative fines imposed on Union institutions, bodies, offices, and agencies.
- ← European Data Protection Supervisor: The European Data Protection Supervisor acts in accordance with Article 100 when imposing administrative fines.
- → Regulation: Article 100 is part of the broader regulation concerning administrative fines.
Article 101
Article 101 outlines fines for providing incorrect, incomplete, or misleading information in the context of AI model evaluations and for failure to provide access as requested.
- → general-purpose AI model: Article 101 includes provisions for fines related to misleading information about the general-purpose AI model.
- → general-purpose AI model: Article 101 lays down rules regarding fines for providing incorrect information related to the general-purpose AI model.
- → providers of general-purpose AI models: Article 101 addresses fines specifically for providers of general-purpose AI models.
- → general-purpose AI models: Article 101 proposes fines for providers of general-purpose AI models for non-compliance.
- → Article 91: Article 101 includes safeguards related to compliance with Article 91.
- → Article 93: Article 101 includes safeguards related to compliance with Article 93.
- → Article 92: Article 101 includes provisions for evaluations as per Article 92.
- ← 12.7.2024: The date 12.7.2024 is associated with Article 101 in the official journal.
Article 102
An article within the regulation that discusses amendments and provisions related to the regulation.
Article 103
An article within the regulation that includes amendments related to artificial intelligence systems.
Article 104
An article that amends Regulation (EU) No 168/2013 by adding a subparagraph regarding delegated acts for AI systems.
- → Regulation (EU) 2024/1689: Article 104 of Regulation (EU) No 168/2013 acts in accordance with the requirements set out in Regulation (EU) 2024/1689.
Article 11
This article specifies the technical documentation requirements for compliance concerning high-risk AI systems.
- → high-risk AI systems: Article 11 outlines the technical documentation required for high-risk AI systems.
- ← Regulation: The regulation includes Article 11, which pertains to the technical documentation.
- ← Regulation 2024/1689: Regulation 2024/1689 includes Article 11 which specifies technical documentation requirements.
- ← Regulation (EU) No 1025/2012: Regulation (EU) No 1025/2012 includes Article 11, which outlines the procedure for evaluation.
- ← Regulation (EU) 2019/2144: Regulation (EU) 2019/2144 includes Article 11 which is amended.
Article 11(1)
A specific article within the regulation that outlines requirements for technical documentation.
- ← Technical documentation: Technical documentation must contain information as applicable to the relevant AI system as per Article 11(1).
Article 112
An article within the regulation that outlines the evaluation and review process by the Commission.
- ← Commission: The Commission is required to assess the need for amendments as outlined in Article 112.
Article 114 TFEU
An article of the Treaty on the Functioning of the European Union that allows for the establishment of measures to ensure the functioning of the internal market.
- ← 2024/1689: The regulation is based on Article 114 of the TFEU to ensure the functioning of the internal market.
Article 12
Article 12 outlines record-keeping requirements for high-risk AI systems, including mechanisms for logging.
- ← High-risk AI systems: High-risk AI systems must comply with the record-keeping requirements outlined in Article 12.
- → Article 79(1): Article 12 includes provisions that ensure compliance with the risk definitions in Article 79(1).
- → Article 72: Article 12 facilitates the post-market monitoring requirements set out in Article 72.
- → Article 26(5): Article 12 outlines monitoring requirements that align with Article 26(5).
- ← high-risk AI system: Article 12 requires mechanisms for logging and interpreting data related to high-risk AI systems.
Article 12(1)
This article outlines the requirements for accessing logs generated by high-risk AI systems.
- ← high-risk AI systems: High-risk AI systems are required to keep logs as specified in Article 12(1).
- ← high-risk AI system: The high-risk AI system must comply with the requirements outlined in Article 12(1) regarding access to logs.
- ← Regulation: The regulation includes Article 12(1), which refers to the logs generated by the AI system.
Article 13
A provision within Directive (EU) 2016/680 that outlines obligations regarding personal data use in law enforcement and risk management for high-risk AI systems.
- → Directive (EU) 2016/680: Article 13 is a specific provision within Directive (EU) 2016/680 that addresses obligations related to personal data.
- ← high-risk AI system: The high-risk AI system requires documentation as specified in Article 13.
- ← High-risk AI systems: High-risk AI systems must ensure transparency as outlined in Article 13.
- ← AI system: The AI system is governed by the instructions outlined in Article 13.
Article 13 of Directive (EU) 2016/680
An article that outlines obligations regarding the right to an explanation for individuals affected by high-risk AI systems.
- ← Regulation (EU) 2016/680: Regulation (EU) 2016/680 includes Article 13, which addresses the right to an explanation for individuals affected by AI systems.
Article 13(3), point (d)
A specific point within an article that discusses the technical measures needed for interpreting AI system outputs.
- ← AI system: The AI system requires documentation on technical measures for output interpretation as outlined in Article 13(3), point (d).
Article 14
This article outlines the requirements for human oversight of high-risk AI systems and the powers of market surveillance authorities within the regulatory framework.
- ← high-risk AI system: Article 14 requires documentation on the design and development of high-risk AI systems for effective human oversight.
- → market surveillance authority: Article 14 provides specific powers and safeguards for the market surveillance authority to enforce regulations.
- ← AI system: The AI system requires documentation regarding human oversight measures as specified in Article 14.
Article 15
Article 15 specifies the metrics, robustness, and cybersecurity standards for testing and validating high-risk AI systems.
- ← High-risk AI systems: High-risk AI systems are tested and validated against the metrics and standards specified in Article 15.
- ← high-risk AI systems: High-risk AI systems must be designed to achieve accuracy, robustness, and cybersecurity as outlined in Article 15.
- ← high-risk AI systems: High-risk AI systems certified under a cybersecurity scheme are presumed to comply with the requirements in Article 15.
- ← European Union: The European Union establishes cybersecurity requirements in Article 15.
- → OJ L, 12.7.2024: Article 15 is published in the official journal on this date.
Article 16
This article specifies the obligations of providers and importers of high-risk AI systems within the regulatory framework.
- ← high-risk AI systems: Article 16 outlines the obligations of providers of high-risk AI systems.
- ← Regulation 2024/1689: Regulation 2024/1689 includes Article 16, which specifies obligations for providers of high-risk AI systems.
- ← Regulation: Article 16 is a part of the regulation that outlines specific obligations for high-risk AI systems.
Article 16 TFEU
Article 16 of the Treaty on the Functioning of the European Union establishes rules for the protection of personal data within the EU.
- ← 2024/1689: The regulation includes specific rules based on Article 16 TFEU concerning the protection of personal data.
- → European Data Protection Board: The regulation on Article 16 TFEU suggests consulting the European Data Protection Board.
- ← Regulation: The Regulation amends the application of Article 16 TFEU regarding the processing of biometric data.
- ← TFEU: Article 16 is a part of the TFEU that deals with personal data protection.
- → personal data: Article 16 TFEU lays down rules for the processing of personal data by Member States.
Article 16(1)
An article within Regulation (EU) 2022/2065 that addresses the processing of notices on illegal content.
- ← Regulation (EU) 2022/2065: Regulation (EU) 2022/2065 includes Article 16(1) which addresses the processing of notices on illegal content.
Article 16(6)
An article within Regulation (EU) 2022/2065 that pertains to the obligations of hosting service providers.
- ← Regulation (EU) 2022/2065: Regulation (EU) 2022/2065 includes Article 16(6) which outlines obligations for hosting service providers.
Article 17
This article outlines the requirements for a quality management system related to high-risk AI systems and their conformity assessment.
Article 18
This article details the documentation requirements that providers of high-risk AI systems must maintain.
Article 18 of Regulation (EU) 2019/1020
An article that applies to measures taken by the market surveillance authority regarding compliance.
Article 19
This article discusses the maintenance of logs generated by high-risk AI systems and provides procedures for notifying serious incidents.
- ← high-risk AI systems: Article 19 discusses the logs that must be kept for high-risk AI systems.
- ← market surveillance authority: The market surveillance authority acts in accordance with the procedures outlined in Article 19 of Regulation (EU) 2019/1020.
- ← Regulation (EU) 2024/1689: Regulation (EU) 2024/1689 includes requirements that must be considered in Article 19 of Regulation (EU) 2018/1139.
Article 2, point (1)(c)
An article within Regulation (EU) No 1025/2012 that defines harmonised standards relevant for compliance with the regulation.
- → Regulation (EU) 2022/2065: This article is part of Regulation (EU) No 1025/2012 and is relevant for demonstrating compliance with Regulation (EU) 2022/2065.
Article 20
This article mandates corrective actions and information provision required for compliance by providers of high-risk AI systems.
Article 21
An article that details the cooperation requirements between providers of high-risk AI systems and competent authorities.
Article 21(6)
An article within Regulation (EU) 2019/1020 that outlines specific tasks for Union AI testing support structures.
Article 22
An article that refers to the committee that the Commission must inform before preparing a draft implementing act.
- ← Commission: The Commission must inform the committee referred to in Article 22 before preparing a draft implementing act.
Article 22(1)
An article mandating the appointment of an authorized representative by the provider of high-risk AI systems, outlining specific regulatory requirements.
- ← Regulation 2024/1689: Regulation 2024/1689 includes Article 22(1) which mandates the appointment of an authorised representative.
Article 24
An article outlining the obligations of distributors regarding high-risk AI systems before they are made available on the market.
- → high-risk AI system: Article 24 specifically addresses the obligations of distributors concerning high-risk AI systems.
Article 25
An article within Regulation 2024/1689 that details the responsibilities along the AI value chain for high-risk AI systems.
- ← Regulation 2024/1689: Regulation 2024/1689 includes Article 25, which outlines responsibilities for high-risk AI systems.
Article 26
An article outlining the obligations of deployers of high-risk AI systems.
- ← high-risk AI systems: Article 26 outlines the obligations of deployers of high-risk AI systems.
- → 12.7.2024: Article 26 is referenced in the context of the regulation dated 12.7.2024.
Article 26(5)
An article that discusses the monitoring of high-risk AI systems.
- ← Article 12: Article 12 outlines monitoring requirements that align with Article 26(5).
Article 27
An article mandating a fundamental rights impact assessment for high-risk AI systems.
Article 27 of Directive (EU) 2016/680
An article that specifies additional requirements for data protection assessments in certain contexts.
- ← AI system: The AI system may need to adhere to additional data protection assessments as per Article 27 of Directive (EU) 2016/680.
Article 28
An article that outlines the responsibilities of notifying authorities in Member States regarding conformity assessment bodies.
- → notifying authorities: Article 28 lays down rules for the establishment and operation of notifying authorities in Member States.
Article 29(2)
Article 29(2) refers to the accreditation certificate required for notified bodies to perform their activities.
- → notified body: Article 29(2) specifies the accreditation certificate required for notified bodies.
Article 29(3)
Article 29(3) refers to the documentary evidence required for notified bodies to perform their activities.
- → notified body: Article 29(3) specifies the documentary evidence required for notified bodies.
Article 290 TFEU
An article of the Treaty on the Functioning of the European Union that allows the delegation of powers to the Commission for adopting acts.
- ← European Commission: The Commission acts in accordance with Article 290 TFEU to amend conditions related to AI systems.
Article 3
Article 3 outlines specific points related to serious incidents involving AI systems that must be reported to the national competent authority.
Article 3, point (4)
An article within Directive (EU) 2016/680 that defines the scope of personal data processing by competent authorities.
- ← Directive (EU) 2016/680: Directive (EU) 2016/680 includes provisions related to personal data processing as outlined in Article 3, point (4).
Article 3, point (5)
An article within Regulation (EU) 2018/1725 that outlines specific provisions related to personal data processing.
- ← Regulation (EU) 2018/1725: Regulation (EU) 2018/1725 includes specific provisions regarding personal data processing as defined in Article 3, point (5).
Article 30
An article detailing the notification procedure for conformity assessment bodies and pertaining to the administrative cooperation group for market surveillance.
- ← Board: The Board's standing sub-group for market surveillance acts in accordance with Article 30 of Regulation (EU) 2019/1020.
Article 30 of Regulation (EU) 2019/1020
An article that outlines the role of the administrative cooperation group (ADCO) for market surveillance under the specified regulation.
- ← Regulation: The Regulation references Article 30 regarding the administrative cooperation group.
Article 31
An article outlining the requirements for conformity assessment bodies, including their establishment, legal personality, and necessary organizational standards.
- ← Conformity Assessment Bodies: Conformity assessment bodies must comply with the requirements specified in Article 31 for notification.
- ← conformity assessment body: Article 31 lays down the requirements that the conformity assessment body must fulfill.
- → notified body: Article 31 lays down the requirements for the establishment and operation of notified bodies.
- ← Article 32: Article 32 presumes compliance with the requirements set out in Article 31 based on adherence to harmonised standards.
- ← Article 33: Article 33 requires notified bodies to ensure that subcontractors meet the requirements laid down in Article 31.
- → notified body: Article 31 lays down the requirements that notified bodies must fulfill.
- ← notified bodies: Notified bodies must comply with the requirements set out in Article 31.
- → notified bodies: Article 31 lays down requirements for the compliance of notified bodies.
Article 32
Article 32 discusses the presumption of conformity with requirements relating to notified bodies, stating that if a conformity assessment body meets certain harmonised standards, it is presumed to comply with the requirements set out in Article 31.
- → Article 31: Article 32 presumes compliance with the requirements set out in Article 31 based on adherence to harmonised standards.
Article 33
Article 33 outlines the responsibilities of notified bodies when subcontracting tasks related to conformity assessment, emphasizing the need for compliance with Article 31 and the accountability of notified bodies for their subcontractors.
- → Article 31: Article 33 requires notified bodies to ensure that subcontractors meet the requirements laid down in Article 31.
Article 33 of Regulation (EU) 2019/1020
An article that mandates the Commission to support market surveillance activities.
- ← Regulation: The Regulation references Article 33 regarding the Commission's support for market surveillance.
Article 34
An article detailing the operational obligations of notified bodies regarding the verification of high-risk AI systems in conformity assessments.
- → Article 43: Article 34 mandates that notified bodies verify the conformity of high-risk AI systems according to the procedures set out in Article 43.
- → Regulation: Article 34 is part of the regulation that specifies operational obligations for notified bodies.
Article 34(4)
An article in Regulation (EU) 2019/1020 that outlines the reporting obligations of market surveillance authorities.
- ← Regulation (EU) 2019/1020: Regulation (EU) 2019/1020 includes Article 34(4), outlining reporting obligations for market surveillance authorities.
Article 35
Article 35 details the assignment of identification numbers to notified bodies and the public availability of their lists.
- ← Regulation (EU) 2016/679: Regulation (EU) 2016/679 includes Article 35, which pertains to data protection impact assessments.
- → Regulation: Article 35 is included in the regulation and discusses identification numbers for notified bodies.
Article 35 of Regulation (EU) 2016/679
An article that outlines the requirements for data protection impact assessments.
- ← AI system: The AI system must comply with data protection impact assessment requirements in Article 35.
Article 36
Article 36 addresses the notification of changes regarding notified bodies to the Commission and Member States.
- → Regulation: Article 36 is part of the regulation and outlines the process for notifying changes to notified bodies.
Article 37
An article in the regulation that addresses challenges to the competence of notified bodies.
- → notified body: Article 37 outlines the process for challenging the competence of notified bodies.
Article 39
An article within the regulation that discusses the authorization of conformity assessment bodies from third countries.
Article 39 of the Charter
An article enshrining the right to vote, which is protected under Union law.
- ← Regulation (EU) 2024/900: Regulation (EU) 2024/900 addresses risks related to the right to vote as enshrined in Article 39.
Article 4
An article in the regulation that addresses AI literacy requirements for providers and deployers of AI systems.
- → general-purpose AI system: Article 4 requires documentation on AI literacy measures for staff dealing with AI systems.
- → downstream provider: Article 4 affects the market by setting standards for AI literacy among downstream providers.
Article 4 (1) of Directive (EU) 2016/680
An article that lays down principles for the processing of personal data, including lawfulness, fairness, and transparency.
- ← Directive (EU) 2016/680: Directive (EU) 2016/680 contains Article 4 (1), which lays down key principles for data processing.
Article 4(2) TEU
An article of the Treaty on European Union that outlines the responsibilities of Member States regarding national security.
- → Member States: Article 4(2) TEU outlines the responsibilities of Member States regarding national security.
Article 4, point (4)
An article within Regulation (EU) 2016/679 that defines profiling in the context of personal data processing.
- ← Regulation (EU) 2016/679: Regulation (EU) 2016/679 includes safeguards related to profiling as defined in Article 4, point (4).
Article 40
An article addressing harmonised standards and standardisation deliverables within the regulation.
- ← Regulation (EU) No 1025/2012: Article 40 references Regulation (EU) No 1025/2012 for standardisation requests.
- → High-risk AI systems: Article 40 specifies parameters for high-risk AI systems in relation to harmonised standards.
- → General-purpose AI models: Article 40 includes provisions for general-purpose AI models regarding compliance with harmonised standards.
- ← Official Journal of the European Union: The Official Journal transmits references of harmonised standards as stated in Article 40.
- → Section 2: Article 40 acts in accordance with the requirements set out in Section 2 of the regulation.
- → Chapter V: Article 40 also acts in accordance with obligations set out in Chapter V of the regulation.
- → AI system: Article 40 lays down rules regarding the presumption of conformity for AI systems.
Article 41
An article discussing the adoption of implementing acts for common specifications and harmonised standards conferring a presumption of conformity.
- ← Regulation (EU) No 1025/2012: Regulation (EU) No 1025/2012 includes Article 41, which outlines common specifications.
- → Regulation (EU) No 1025/2012: Article 41 acts in accordance with the provisions set out in Regulation (EU) No 1025/2012.
- → AI system: Article 41 lays down additional rules regarding the presumption of conformity for AI systems.
Article 43
This article outlines the conformity assessment procedures for high-risk AI systems prior to their market placement, including fees for SMEs.
- ← high-risk AI systems: Article 43 outlines the conformity assessment procedure for high-risk AI systems.
- ← high-risk AI system: The high-risk AI system must comply with the conformity assessment procedure outlined in Article 43.
- ← Regulation 2024/1689: Regulation 2024/1689 includes Article 43 detailing conformity assessment procedures.
- ← Article 34: Article 34 mandates that notified bodies verify the conformity of high-risk AI systems according to the procedures set out in Article 43.
- → high-risk AI systems: Article 43 outlines the standard conformity assessment procedures that may be amended for high-risk AI systems.
- ← CE marking: The CE marking is associated with the conformity assessment procedures outlined in Article 43.
- → SMEs: Article 43 requires that fees for conformity assessment be adjusted based on the size and market of SMEs.
- ← Regulation (EU) 2024/1689: Regulation (EU) 2024/1689 includes requirements that must be considered in Article 43 of Regulation (EU) 2018/1139.
- → Artificial Intelligence systems: Article 43 lays down rules for the adoption of implementing acts concerning AI systems.
Article 43(4)
A specific article that outlines the conditions under which changes to the AI systems require a new conformity assessment.
- → changes: Article 43(4) outlines the documentation requirements for changes to the AI systems.
Article 45
A specific article that outlines the information obligations of notified bodies regarding conformity assessment.
- ← notified body: Article 45 outlines the information obligations that notified bodies must follow.
Article 47
This article details the requirements for drawing up an EU declaration of conformity for high-risk AI systems.
- ← high-risk AI systems: Article 47 details the requirements for the EU declaration of conformity for high-risk AI systems.
- ← high-risk AI system: The high-risk AI system must draw up an EU declaration of conformity as per Article 47.
- → high-risk AI systems: Article 47 refers to the EU declaration of conformity required for high-risk AI systems.
- ← EU declaration of conformity: The EU declaration of conformity is referenced in Article 47 of the regulation.
- ← Regulation: The regulation includes Article 47, which pertains to the EU declaration of conformity.
- ← Regulation 2024/1689: Regulation 2024/1689 includes Article 47 regarding the EU declaration of conformity.
- → Artificial Intelligence systems: Article 47 lays down rules for the adoption of delegated acts concerning AI systems.
- ← AI system: The AI system requires an EU declaration of conformity as specified in Article 47.
- → AI system: Article 47 lays down rules for the conformity declaration of the AI system.
Article 48
Specifies the requirements for affixing the CE marking to high-risk AI systems.
- ← high-risk AI system: The high-risk AI system must affix the CE marking in accordance with Article 48.
Article 49
An article detailing registration requirements for high-risk AI systems in the EU database before market placement.
Article 49(1)
This article outlines the registration obligations for providers of high-risk AI systems.
- ← high-risk AI system: The high-risk AI system must comply with registration obligations as stated in Article 49(1).
- ← Regulation: The regulation includes Article 49(1), which details registration obligations.
- ← Regulation 2024/1689: Regulation 2024/1689 includes Article 49(1) which outlines registration obligations.
Article 49(2)
Article 49(2) details the registration obligations for providers of AI systems that are not classified as high-risk.
- ← provider: Providers of AI systems must document their assessment of risk before placing the system on the market as stipulated in Article 49(2).
- ← AI system: The AI system must provide specific information as outlined in Article 49(2).
Article 49(3)
An article that mandates the submission of information by deployers of high-risk AI systems.
- ← AI system: The AI system requires documentation to be submitted by its deployer as per Article 49(3).
Article 49(4)
A provision that specifies the requirements for registering testing in real-world conditions for high-risk AI systems.
- ← EU database: The EU database includes provisions outlined in Article 49(4) for testing registration.
Article 49(5)
A provision that outlines additional requirements for providers of high-risk AI systems regarding testing in real-world conditions.
- ← EU database: The EU database includes provisions outlined in Article 49(5) for testing registration.
Article 5
An article that specifies prohibited AI practices and associated penalties for non-compliance within the regulatory framework.
- → general-purpose AI system: Article 5 proposes regulations on prohibited AI practices that may involve general-purpose AI systems.
- → Prohibited AI practices: Article 5 specifically addresses the prohibited practices related to AI systems.
- → high-risk AI systems: Article 5 proposes prohibitions that must be adhered to during the testing of high-risk AI systems.
- ← AI system: The AI system must comply with the prohibitions outlined in Article 5.
- → AI system: Article 5 prohibits certain AI practices that require documentation for compliance.
- ← Commission: The Commission evaluates national measures based on the prohibitions outlined in Article 5.
- ← Article 99: Article 99 specifies penalties for non-compliance with the prohibitions outlined in Article 5.
- → administrative fine: Article 5 specifies the prohibited AI practices that can lead to administrative fines.
- ← regulation 2024/1689: Regulation 2024/1689 includes Article 5, which outlines prohibited practices.
- → EUR 1 500 000: Article 5 lays down the rules for the maximum fine for non-compliance with prohibited AI practices.
- ← regulation: Article 5 of the Regulation specifies prohibited practices for AI systems.
- → Annex III: Article 5 lays down the list of prohibited AI practices which is referenced in Annex III.
Article 5 TEU
An article in the Treaty on European Union outlining the principles of subsidiarity and proportionality.
- → principle of subsidiarity: This article safeguards the principle of subsidiarity in the EU's decision-making process.
- → Regulation: The Regulation is implemented in accordance with the principles outlined in Article 5 of the TEU.
Article 50
An article outlining provisions for the deployment of high-risk AI systems, including transparency obligations and compliance requirements.
- ← high-risk AI systems: High-risk AI systems must comply with the provisions outlined in Article 50 of the regulation.
- → natural persons: Article 50 lays down rules requiring that natural persons are informed when interacting with AI systems.
- ← AI system: The AI system must comply with the requirements outlined in Article 50.
- → AI system: Article 50 addresses non-compliance issues related to AI systems.
- → Commission: Article 50 requires the Commission to evaluate AI systems needing additional transparency measures.
- ← Regulation: Article 50 specifies additional transparency measures for certain AI systems.
Article 51
An article that defines classification rules and conditions for general-purpose AI models to avoid being classified as presenting systemic risks.
- → general-purpose AI model: Article 51 establishes rules for the classification and assessment of general-purpose AI models with systemic risk.
- ← Article 90: Article 90 references Article 51 for conditions related to systemic risks.
- ← General-purpose AI models: General-purpose AI models are evaluated based on the criteria set out in Article 51.
Article 52
An article outlining the procedure for notifying the Commission regarding the classification and regulation of general-purpose AI models.
- → Commission: Article 52 outlines the procedure for providers to notify the Commission about general-purpose AI models.
- ← OJ L, 12.7.2024: The date indicates when Article 52 was published in the official journal.
Article 53
An article outlining obligations for providers of AI models, particularly regarding information updates in light of market developments.
- ← general-purpose AI model: The general-purpose AI model must comply with obligations outlined in Article 53.
- ← Article 55: Article 55 includes additional obligations beyond those listed in Article 53.
- ← codes of practice: The codes of practice must cover the obligations provided for in Article 53.
- ← AI Office: The AI Office requires adherence to the obligations outlined in Article 53 for AI model providers.
- ← Commission: The Commission may request providers to take measures to comply with obligations set out in Article 53.
Article 53(1)
An article outlining the requirements for technical documentation related to AI models, particularly general-purpose models.
Article 53(1), point (b)
A specific article in the regulation that outlines requirements for technical documentation.
- ← evaluation strategies: Evaluation strategies must comply with the requirements set in Article 53(1), point (b).
Article 54
An article that complements the obligations outlined in Article 53 with additional compliance requirements.
- ← Article 55: Article 55 complements the obligations outlined in Article 54.
- ← Commission: The Commission may request providers to take measures to comply with obligations set out in Article 54.
Article 54(3)
An article within Regulation (EU) 2019/881 that pertains to the compliance of high-risk AI systems with cybersecurity requirements.
Article 55
An article specifying additional obligations for providers of general-purpose AI models with systemic risk, including those covered by codes of practice.
- ← general-purpose AI model: The general-purpose AI model may also need to comply with additional obligations in Article 55.
- ← Regulation 2024/1689: Regulation 2024/1689 includes Article 55, which details specific obligations for AI model providers.
- ← general-purpose AI models with systemic risk: Providers must document and report information about serious incidents related to these AI models.
- → Article 53: Article 55 includes additional obligations beyond those listed in Article 53.
- → Article 54: Article 55 complements the obligations outlined in Article 54.
- → Article 56: Providers may rely on codes of practice as per Article 56 to demonstrate compliance.
- → Article 78: Confidentiality obligations for information obtained under Article 55 are outlined in Article 78.
- ← codes of practice: The codes of practice must also include the obligations outlined in Article 55.
Article 56
An article that refers to codes of practice for compliance with obligations related to AI systems.
- ← Regulation 2024/1689: Regulation 2024/1689 includes Article 56, which pertains to codes of practice for compliance.
- ← Article 55: Providers may rely on codes of practice as per Article 56 to demonstrate compliance.
Article 56 (6)
An article that details the procedure for the Commission to adopt implementing acts related to codes of practice.
- → codes of practice: The procedure for adopting implementing acts is outlined in Article 56 (6) of the regulation.
- ← Commission: The Commission acts in accordance with Article 56 (6) to adopt implementing acts for codes of practice.
Article 57
An article in the regulation detailing specific conditions for conducting real-world testing of AI systems.
Article 58
An article detailing the establishment and functioning of AI regulatory sandboxes within the European Union.
- → AI regulatory sandboxes: Article 58 contains provisions regarding the detailed arrangements for AI regulatory sandboxes.
- → Article 98(2): The provisions in Article 58 must be adopted in accordance with the examination procedure outlined in Article 98(2).
- → Artificial Intelligence systems: Article 58 lays down rules for the adoption of delegated acts concerning AI systems.
Article 59
A specific provision within the regulation that addresses the further processing of personal data for developing AI systems in the public interest.
- → AI regulatory sandbox: Article 59 lays down the rules for the further processing of personal data within the AI regulatory sandbox.
Article 6
An article within the regulation that outlines the classification rules for high-risk AI systems.
- → high-risk AI systems: Article 6 outlines the classification rules for identifying high-risk AI systems.
- ← Regulation 2024/1689: Regulation 2024/1689 includes Article 6, which defines the criteria for high-risk AI systems.
Article 6(3)
An article that outlines the criteria and procedures for classifying AI systems as high-risk or not-high-risk.
- → provider: Article 6(3) lays down rules for determining if a provider's AI system is high-risk.
- ← AI system: AI systems are classified as high-risk or non-high-risk based on the conditions set out in Article 6(3).
- ← AI system: The AI system's classification as not-high-risk is based on conditions specified in Article 6(3).
Article 60
An article outlining additional conditions and procedures for testing high-risk AI systems, including those outside regulatory sandboxes.
- → testing in real-world conditions: Article 60 provides additional conditions for testing in real-world conditions.
- ← High-risk AI systems: High-risk AI systems must be tested in accordance with the procedures outlined in Article 60.
- → high-risk AI systems: Article 60 specifically addresses the testing procedures for high-risk AI systems.
- → market surveillance authorities: Article 60 specifies that certain information in the EU database is accessible only to market surveillance authorities.
- ← Market Surveillance Authority: The market surveillance authority verifies compliance with Article 60 as part of its supervisory role.
- → Annex IX: Article 60 includes safeguards regarding the registration of high-risk AI systems as detailed in Annex IX.
Article 61
An article outlining the requirements for obtaining informed consent from subjects involved in testing AI systems.
Article 62
An article discussing measures for providers and deployers of AI systems, particularly focusing on SMEs and start-ups.
- → SMEs: Article 62 specifically addresses measures for providers and deployers, including small and medium-sized enterprises (SMEs).
- → AI regulatory sandboxes: Article 62 outlines measures for providing SMEs access to AI regulatory sandboxes.
- ← AI Office: The AI Office is tasked with actions that align with the provisions of Article 62.
Article 62(1), point (c)
A specific provision that outlines the requirements for interaction with AI regulatory sandboxes.
- ← AI regulatory sandbox: The AI regulatory sandbox is governed by specific articles including Article 62(1), point (c).
Article 63
An article in the regulation that discusses derogations for specific operators, particularly microenterprises.
- → Regulation 2024/1689: Article 63 is part of Regulation 2024/1689 and discusses derogations for microenterprises.
Article 64
An article that outlines the governance structure at the Union level, specifically regarding the AI Office.
- → AI Office: Article 64 outlines the governance structure related to the AI Office.
Article 65
An article outlining the establishment and structure of the European Artificial Intelligence Board.
Article 66
An article detailing the tasks of the European Artificial Intelligence Board in relation to the regulation.
Article 67
An article within a regulation that refers to the advisory forum for consultation during the drafting of common specifications.
- ← Commission: The Commission shall consult the advisory forum as referred to in Article 67 when drafting common specifications.
Article 68
Article 68 establishes the criteria for appointing independent experts to conduct evaluations of AI models and discusses the establishment of a scientific panel.
- ← scientific panel: The scientific panel is established in accordance with Article 68 of the regulation.
- → independent experts: Article 68 outlines the criteria for appointing independent experts for evaluations.
Article 68(1)
An article within the Regulation that refers to the implementing act concerning the structure and level of fees for expert advice.
- → Regulation: Article 68(1) refers to the implementing act that amends the structure and level of fees.
Article 69
An article that outlines the access of Member States to the pool of experts by the scientific panel.
- ← Regulation 2024/1689: Regulation 2024/1689 includes Article 69, which outlines access to the pool of experts.
Article 7
An article within the regulation that empowers the Commission to adopt delegated acts to amend Annex III.
- ← Regulation: The regulation includes Article 7, which outlines the conditions for amending Annex III.
- → Annex III: Article 7 empowers the Commission to amend Annex III regarding high-risk AI systems.
- → AI systems: Article 7 lays down rules for assessing high-risk AI systems based on specific criteria.
Article 70
An article that outlines the designation of national competent authorities and single points of contact.
- ← Member States: Article 70 outlines the requirements for national competent authorities.
Article 71
An article referring to the EU database for the registration of high-risk AI systems, containing compliance-related information.
- ← deployers of high-risk AI systems: Deployers must inform the provider or distributor if the high-risk AI system is not registered in the EU database referenced in Article 71.
- → EU database: Article 71 refers to the EU database where high-risk AI systems must be registered.
- ← Regulation (EU) 2019/1020: Regulation (EU) 2019/1020 includes safeguards related to the EU database mentioned in Article 71.
Article 71(4)
A legal provision that requires registration of testing in real-world conditions with a unique identification number.
Article 72
Article 72 outlines the post-market monitoring system and risk management measures for high-risk AI systems, including obligations for deployers.
- ← high-risk AI system: High-risk AI systems must follow the risk management rules set out in Article 72, including implementing a post-market monitoring system.
- ← Article 12: Article 12 facilitates the post-market monitoring requirements set out in Article 72.
- ← AI system: The AI system must have a system in place to evaluate its performance in the post-market phase as per Article 72.
- ← Conformity assessment procedure based on internal control: The conformity assessment procedure requires documentation related to the design and development process as per Article 72.
- → AI system: The design and development process of the AI system must act in accordance with Article 72.
Article 73
This article outlines the procedures for reporting serious incidents related to high-risk AI systems.
- ← high-risk AI system: The high-risk AI system must follow procedures for reporting serious incidents as stated in Article 73.
- → Market Surveillance Authorities: Article 73 requires providers to report serious incidents to the national market surveillance authority.
- ← OJ L, 12.7.2024: The date indicates when the regulation including Article 73 was published.
Article 74
A provision in the regulatory framework that outlines the role of market surveillance authorities and information exchange.
- → notified bodies: Article 74 specifies the role of market surveillance authorities as notified bodies.
- ← market surveillance authorities: Article 74 outlines the obligations of market surveillance authorities in relation to high-risk AI systems.
Article 74(10)
An article that specifies the obligations of the competent authorities and national authorities regarding the high-risk AI system.
- ← Regulation: The regulation includes Article 74(10), which outlines the obligations of competent authorities.
Article 74(11)
An article that refers to cross-border market surveillance activities.
- ← Regulation 2024/1689: Regulation 2024/1689 includes Article 74(11), which refers to cross-border market surveillance activities.
Article 76
An article that outlines the supervision of testing in real-world conditions by market surveillance authorities.
Article 77
This article outlines the powers of national public authorities or bodies in supervising and enforcing obligations under Union law related to fundamental rights, particularly concerning high-risk AI systems.
- → market surveillance authority: Article 77 grants powers to national public authorities to request documentation from the market surveillance authority.
Article 77(1)
Article 77(1) outlines cooperation requirements for operators and authorities, emphasizing consultation with relevant national public authorities regarding AI systems.
Article 78
This article sets out confidentiality obligations for information obtained by competent authorities and during conformity assessment activities.
- ← competent authority: The competent authority must treat information obtained in accordance with the confidentiality obligations set out in Article 78.
- ← Notifying Authorities: Notifying authorities are required to maintain confidentiality as outlined in Article 78.
- ← Notified Bodies: Notified bodies must maintain confidentiality as outlined in Article 78 during conformity assessment activities.
- ← Notified Bodies: Notified bodies must maintain confidentiality as required by Article 78.
- → notified bodies: Article 78 includes safeguards for the confidentiality of information obtained by notified bodies.
- ← AI Office: The AI Office must treat information in accordance with the confidentiality obligations set out in Article 78.
- ← Article 55: Confidentiality obligations for information obtained under Article 55 are outlined in Article 78.
- → exit report: Article 78 outlines confidentiality provisions regarding the access to exit reports.
- ← national competent authorities: National competent authorities must adhere to the confidentiality obligations outlined in Article 78.
- ← Market surveillance authorities: Market surveillance authorities must treat information according to the confidentiality obligations set out in Article 78.
- → national public authorities or bodies: Article 78 establishes confidentiality obligations for information obtained by national public authorities or bodies.
- ← Regulation (EU) 2024/1689: Regulation (EU) 2024/1689 includes Article 78, which details confidentiality obligations.
- → Directive (EU) 2016/943: Article 78 references Directive (EU) 2016/943 regarding confidentiality exceptions.
- → Union law: Article 78 requires compliance with Union law regarding confidentiality.
- → national law: Article 78 requires compliance with national law regarding confidentiality.
Article 79
An article defining the risks associated with high-risk AI systems, outlining distributor responsibilities and the procedures for corrective actions and compliance evaluations.
- ← distributors: Distributors must comply with the risk assessment requirements outlined in Article 79.
- → Regulation (EU) 2019/1020: Article 79 is part of Regulation (EU) 2019/1020, detailing procedures for AI systems presenting risks.
- ← AI system: Article 79 requires documentation of corrective actions for AI systems.
- → AI systems: Article 79 lays down rules for the evaluation of AI systems to ensure compliance.
Article 79(1)
Article 79(1) defines conditions under which a high-risk AI system may present a risk or be considered non-compliant.
- ← Article 12: Article 12 includes provisions that ensure compliance with the risk definitions in Article 79(1).
- ← high-risk AI system: Article 79(1) outlines the conditions under which a high-risk AI system is deemed non-compliant.
Article 8
An article that outlines the compliance requirements for high-risk AI systems.
- → AI system: Article 8 lays down compliance requirements for high-risk AI systems.
Article 80
An article that outlines the procedure for dealing with AI systems classified as non-high-risk.
Article 83
Article 83 addresses formal non-compliance regarding the affixing of CE markings and related documentation.
- → Article 84: Article 83 outlines compliance requirements that may be relevant to the provisions in Article 84.
Article 84
Article 84 designates Union AI testing support structures for tasks related to AI, focusing on enhancing testing capabilities.
- → scientific panel: Union AI testing support acts in accordance with the scientific panel's recommendations.
- ← Article 83: Article 83 outlines compliance requirements that may be relevant to the provisions in Article 84.
Article 85
An article that grants the right to lodge a complaint with a market surveillance authority regarding infringements of the regulation.
Article 86
An article that provides the right to explanation of individual decision-making based on outputs from high-risk AI systems.
- ← Regulation (EU) 2019/1020: Regulation (EU) 2019/1020 includes Article 86, which provides rights related to decision-making explanations.
- → high-risk AI system: Article 86 addresses the implications of high-risk AI systems on individual rights and market practices.
Article 87
An article that outlines the reporting of infringements and the protection of reporting persons under Directive (EU) 2019/1937.
- ← Directive (EU) 2019/1937: Directive (EU) 2019/1937 includes Article 87, which pertains to reporting infringements.
- ← Union Law: Union law may provide exceptions or restrictions to the obligations outlined in Article 87.
Article 88
An article that discusses the enforcement of obligations for providers of general-purpose AI models.
- ← Regulation 2024/1689: Regulation 2024/1689 includes Article 88, which discusses enforcement obligations for AI model providers.
Article 89
An article that details the monitoring actions that the AI Office can take regarding compliance with the regulation.
Article 9
An article addressing the requirements for a risk management system for high-risk AI systems, including the processing of biometric data.
- ← real-time remote biometric identification systems: The use of biometric identification systems must comply with the stipulations of Article 9 regarding the processing of biometric data.
- → AI system: Article 9 refers to the risk management system that must be considered for compliance of high-risk AI systems.
- → risk management system: Article 9 specifies the requirements for the risk management system that must be implemented for high-risk AI systems.
- ← high-risk AI system: The high-risk AI system must comply with the risk management system outlined in Article 9.
- ← Regulation (EU) 2019/1020: Article 9 is part of Regulation (EU) 2019/1020, which addresses high-risk AI systems.
- ← AI system: The AI system must have a risk management system as outlined in Article 9.
- ← AI system: The AI system must have a detailed risk management system as outlined in Article 9.
Article 9(2)
Article 9(2) refers to fundamental rights that may be at risk when using high-risk AI systems.
- ← High-risk AI systems: The use of high-risk AI systems may lead to risks that affect fundamental rights as stated in Article 9(2).
- ← high-risk AI system: Article 9(2) lays down rules regarding the safety and fundamental rights related to high-risk AI systems.
Article 90
Article 90 provides a framework for addressing systemic risks associated with general-purpose AI models, allowing the scientific panel to alert the AI Office about potential risks.
- → AI Office: Article 90 requires the scientific panel to alert the AI Office of possible systemic risks.
- → Regulation 2024/1689: Article 90 is part of Regulation 2024/1689 and discusses alerts of systemic risks.
- → Article 51: Article 90 references Article 51 for conditions related to systemic risks.
- → scientific panel: Article 90 allows the scientific panel to provide opinions regarding systemic risks of AI models.
Article 91
Article 91 pertains to requests for documents or information that must be complied with by providers of AI models.
- ← Article 101: Article 101 includes safeguards related to compliance with Article 91.
Article 92
Article 92 grants the AI Office the power to conduct evaluations of general-purpose AI models to assess compliance and investigate systemic risks.
- ← AI Office: The AI Office conducts evaluations as outlined in Article 92.
- ← general-purpose AI model: The evaluation of the general-purpose AI model may give rise to concerns about systemic risks at the Union level as outlined in Article 92.
- ← Article 101: Article 101 includes provisions for evaluations as per Article 92.
Article 93
Article 93 includes measures that must be complied with by providers of AI models.
- ← Article 101: Article 101 includes safeguards related to compliance with Article 93.
Article 94
Article 94 addresses procedural guarantees relevant to the supervision and enforcement of AI regulations, focusing on the rights of economic operators.
- → Regulation (EU) 2019/1020: Article 94 applies the provisions of Regulation (EU) 2019/1020 to providers of general-purpose AI models.
Article 96
Article 96 provides guidelines for the practical implementation of regulations concerning AI systems.
- ← European Artificial Intelligence Board: The Board acts in accordance with Article 96 to provide guidelines for the implementation of AI regulations.
- → Regulation: Article 96 specifies guidelines for the practical implementation of the regulation concerning AI systems.
Article 97
Article 97 empowers the Commission to adopt delegated acts to amend existing regulations and lists regarding high-risk AI systems.
- → Regulation: Article 97 allows the Commission to amend conditions laid down in the regulation based on evidence regarding AI systems.
- → Annex III: Article 97 empowers the Commission to amend the list in Annex III by removing high-risk AI systems.
- ← Commission: The Commission acts in accordance with Article 97 to amend Annex IV and adopt necessary delegated acts.
- → Annex V: Article 97 allows for amendments to Annex V regarding the EU declaration of conformity.
- ← Commission: The Commission proposes to adopt delegated acts in accordance with Article 97 to amend thresholds and benchmarks.
Article 97(2)
An article that empowers the Commission to amend specific annexes in light of technological developments.
- ← Commission: The Commission acts in accordance with Article 97(2) to amend annexes based on technological developments.
Article 98
Article 98 details the examination procedure for adopting implementing acts and outlines the committee procedure and the role of the Commission.
- ← Commission: The Commission adopts implementing acts in accordance with the examination procedure outlined in Article 98.
- ← Regulation (EU) No 182/2011: Regulation (EU) No 182/2011 includes Article 98 which outlines the committee procedure.
Article 98(2)
An article outlining the examination procedure for adopting implementing acts related to AI models and regulatory sandboxes.
- ← Commission: The Commission acts in accordance with Article 98(2) for implementing obligations regarding AI models.
- ← Article 58: The provisions in Article 58 must be adopted in accordance with the examination procedure outlined in Article 98(2).
- ← scientific panel: The scientific panel's establishment follows the examination procedure outlined in Article 98(2).
- → implementing act: Article 98(2) lays down the rules for the examination procedure for adopting implementing acts.
Article 99
Article 99 specifies penalties, including fines, for non-compliance with AI system regulations.
- ← provider: If the provider fails to comply with the requirements, they are subject to fines as specified in Article 99.
- ← AI system: Article 99 lays down rules regarding fines for non-compliance of AI systems.
- ← Regulation (EU) No 182/2011: Regulation (EU) No 182/2011 includes Article 99 which details penalties for infringements.
- → Article 5: Article 99 specifies penalties for non-compliance with the prohibitions outlined in Article 5.
- → SMEs: Article 99 takes into account the interests of SMEs when determining penalties.
- → EUR 35 000 000: Article 99 specifies a maximum fine of EUR 35 000 000 for non-compliance.
- → 7 %: Article 99 states that fines for undertakings can be up to 7% of their total worldwide annual turnover.
Articles 29 and 30
Articles that lay down procedures applicable to extensions of the scope of notifications for notified bodies.
- → notified body: These articles establish the procedures that the notified body must follow for notification changes.
Articles 40 and 41
Articles 40 and 41 refer to harmonised standards or common specifications that confer a presumption of conformity for AI systems.
- ← AI system: The AI system must adhere to harmonised standards or common specifications as per Articles 40 and 41.
- ← Commission: The Commission applies procedures related to shortcomings in harmonised standards as referred to in Articles 40 and 41.
Articles 53 and 55
Specific articles within a regulation that outline obligations related to the codes of practice.
- ← codes of practice: The codes of practice must cover the obligations outlined in Articles 53 and 55.
Articles 79 to 83
Specific articles within a regulation that detail procedures related to market surveillance.
Articles 91 to 94
Specific articles that outline the powers and procedures related to the assessment of AI models.
- → AI Office: Articles 91 to 94 lay down the rules for the powers of the AI Office.
Artificial Intelligence Act
The Artificial Intelligence Act, also known as Regulation (EU) 2024/1689, establishes rules and requirements for artificial intelligence systems within the EU.
- ← Regulation (EU) 2024/1689: Regulation (EU) 2024/1689 is part of the Artificial Intelligence Act.
- → Directive 2014/90/EU: The Artificial Intelligence Act amends Directive 2014/90/EU to include provisions for AI systems.
- → Directive (EU) 2016/797: The Artificial Intelligence Act amends Directive (EU) 2016/797 to incorporate AI-related provisions.
- ← Regulation (EU) 2024/1689: Regulation (EU) 2024/1689 is also known as the Artificial Intelligence Act.
- → Directive (EU) 2020/1828: The Artificial Intelligence Act amends Directive (EU) 2020/1828.
- → 13 June 2024: The date of establishment for the Artificial Intelligence Act.
- → 31 December 2030: The compliance deadline for AI systems placed on the market before 2 August 2027.
- → 2 August 2027: The date before which AI systems must be placed on the market to comply with the regulation.
Artificial Intelligence Act
Regulation (EU) 2024/1689 establishes harmonised rules on artificial intelligence and amends several previous regulations and directives.
- ← Regulation (EU) 2024/1689: Regulation (EU) 2024/1689 is part of the Artificial Intelligence Act.
- → Directive 2014/90/EU: The Artificial Intelligence Act amends Directive 2014/90/EU to include provisions for AI systems.
- → Directive (EU) 2016/797: The Artificial Intelligence Act amends Directive (EU) 2016/797 to incorporate AI-related provisions.
- ← Regulation (EU) 2024/1689: Regulation (EU) 2024/1689 is also known as the Artificial Intelligence Act.
- → Directive (EU) 2020/1828: The Artificial Intelligence Act amends Directive (EU) 2020/1828.
- → 13 June 2024: The date of establishment for the Artificial Intelligence Act.
- → 31 December 2030: The compliance deadline for AI systems placed on the market before 2 August 2027.
- → 2 August 2027: The date before which AI systems must be placed on the market to comply with the regulation.
Artificial Intelligence Act
The colloquial name for Regulation (EU) 2024/1689, focusing on the regulation of AI systems.
- ← Regulation (EU) 2024/1689: Regulation (EU) 2024/1689 is part of the Artificial Intelligence Act.
- → Directive 2014/90/EU: The Artificial Intelligence Act amends Directive 2014/90/EU to include provisions for AI systems.
- → Directive (EU) 2016/797: The Artificial Intelligence Act amends Directive (EU) 2016/797 to incorporate AI-related provisions.
- ← Regulation (EU) 2024/1689: Regulation (EU) 2024/1689 is also known as the Artificial Intelligence Act.
- → Directive (EU) 2020/1828: The Artificial Intelligence Act amends Directive (EU) 2020/1828.
- → 13 June 2024: The date of establishment for the Artificial Intelligence Act.
- → 31 December 2030: The compliance deadline for AI systems placed on the market before 2 August 2027.
- → 2 August 2027: The date before which AI systems must be placed on the market to comply with the regulation.
Artificial Intelligence systems
Systems that utilize AI technology, specifically those classified as safety components in the context of the regulation.
- ← Article 43: Article 43 lays down rules for the adoption of implementing acts concerning AI systems.
- ← Article 47: Article 47 lays down rules for the adoption of delegated acts concerning AI systems.
- ← Article 57: Article 57 lays down rules for implementing acts concerning AI systems.
- ← Article 58: Article 58 lays down rules for the adoption of delegated acts concerning AI systems.
artists, authors, and other creators
Individuals who create content and may be affected by the use of AI in the creation and distribution of their works.
- → large generative AI models: The emergence of large generative AI models presents both opportunities and challenges for creators in the market.
asylum
An area of application for high-risk AI systems related to the processing of asylum claims.
asylum authorities
Agencies that process applications for asylum and provide protection to individuals fleeing persecution.
- ← Regulation: The Regulation specifies how asylum authorities should conduct identity checks in compliance with the law.
audit report
A report provided by the notified body after conducting audits to ensure compliance with the quality management system.
- ← notified body: The notified body provides an audit report to the provider after conducting audits.
Authorised representative
A person or entity established in the Union that acts on behalf of providers from third countries to ensure compliance of AI systems.
- ← Providers from third countries: Providers must appoint an authorised representative in the Union to ensure compliance before making AI systems available.
authorised representative
A representative appointed by a provider to fulfill regulatory obligations on their behalf within the Union.
- ← provider: The provider mandates the authorised representative to perform obligations on its behalf.
- → Union market: The authorised representative must ensure that the high-risk AI systems are compliant before they are made available on the Union market.
- → mandate: The tasks of the authorised representative are defined by the mandate received from the provider.
automation bias
The tendency of users to rely excessively on the output of high-risk AI systems, potentially leading to errors in decision-making.
- ← human oversight: Human oversight aims to mitigate the risks associated with automation bias in high-risk AI systems.
basic supplies
Essential goods and services necessary for the population's survival and well-being.
- ← identity checks: The conduct of identity checks can impact the provision of basic supplies to the population.
benchmarks
Benchmarks are standards used to evaluate the performance and capabilities of high-risk AI systems and general-purpose AI models.
- ← Commission: The Commission encourages the development of benchmarks for measuring the performance of high-risk AI systems.
- ← scientific panel: The scientific panel contributes to the development of benchmarks for evaluating AI models.
biometric categorisation
The classification of individuals based on their biometric data, used in various applications including law enforcement.
- → Digital Services Act: The Digital Services Act lays down rules for the use of biometric categorisation in digital services.
biometric categorisation
The process of assigning natural persons to specific categories based on their biometric data, such as sex, age, and other traits.
- → Digital Services Act: The Digital Services Act lays down rules for the use of biometric categorisation in digital services.
biometric categorisation system
An AI system that categorizes individuals based on their biometric data.
- → biometric data: The biometric categorisation system uses biometric data to categorize individuals.
- → personal data: Deployers must inform individuals about the operation of the biometric categorisation system and how personal data is processed.
biometric categorisation systems
AI systems designed to categorize individuals based on biometric data, often used in law enforcement and regulated under data protection laws.
- ← Ireland: Ireland is not bound by rules regarding the use of biometric categorisation systems for police cooperation.
- → Article 5(1): The use of biometric categorisation systems is governed by Article 5(1) of the regulation.
- → natural persons: The regulation lays down rules for the use of biometric categorisation systems that infer personal characteristics.
biometric data
Biometric data is a special category of personal data derived from physical, physiological, or behavioral characteristics of individuals, used for identification purposes.
- ← Regulation (EU) 2016/679: Regulation (EU) 2016/679 defines biometric data in Article 4, point (14).
- ← Regulation (EU) 2018/1725: Regulation (EU) 2018/1725 defines biometric data in Article 3, point (18).
- ← Directive (EU) 2016/680: Directive (EU) 2016/680 defines biometric data in Article 3, point (13).
- ← Regulation (EU) 2016/679: Regulation (EU) 2016/679 lays down rules for the processing of biometric data.
- ← Regulation (EU) 2018/1725: Regulation (EU) 2018/1725 includes safeguards for the processing of biometric data.
- ← Directive (EU) 2016/680: Directive (EU) 2016/680 lays down rules for the processing of biometric data by competent authorities.
- ← remote biometric identification system: The remote biometric identification system utilizes biometric data for the identification of individuals.
- ← real-time systems: Real-time systems utilize biometric data for immediate identification processes.
- ← emotion recognition system: The emotion recognition system processes biometric data to identify emotions.
- → AI system: The regulation prohibits the use of biometric data for manipulative practices while allowing lawful categorization.
- ← AI systems: AI systems utilize biometric data for identification and to infer emotions or intentions.
- → AI system: The classification of biometric data as high-risk affects the market for AI systems utilizing such data.
- ← AI systems: AI systems may process biometric data to identify or infer emotions or intentions of natural persons.
- ← biometric categorisation system: The biometric categorisation system uses biometric data to categorize individuals.
- ← real-time remote biometric identification system: The real-time remote biometric identification system uses biometric data for immediate identification.
- ← post-remote biometric identification system: The post-remote biometric identification system uses biometric data for identification, but not in real-time.
- ← Regulation (EU) 2016/679: The regulation includes safeguards for the processing of biometric data for purposes other than law enforcement.
- ← law enforcement: Law enforcement agencies are subject to specific rules regarding the use of biometric data in public spaces.
- ← natural persons: Natural persons are the users whose biometric data is being processed under the regulation.
biometric identification systems
AI systems that use biometric data for identification purposes, which may have significant consequences if they produce incorrect matches.
- ← natural persons: Natural persons must verify and confirm the outputs of biometric identification systems to prevent incorrect actions based on their results.
Biometrics
AI systems related to biometric identification and categorization, including remote identification and emotion recognition.
- → High-risk AI systems: Biometric AI systems are included as high-risk AI systems under specific conditions.
Board
A governing body that advises the Commission and Member States on AI system regulations, coordinates activities among national authorities, and ensures effective implementation of codes of practice.
- ← Commission: The Commission consults the Board to provide guidelines for the implementation of AI system regulations.
- → Regulation: The Board is established to facilitate the implementation of the Regulation.
- → Member States: The Board is composed of representatives from Member States.
- → market surveillance authorities: The Board establishes sub-groups for cooperation among market surveillance authorities.
- → Advisory Forum: The Board proposes the establishment of an Advisory Forum to ensure stakeholder involvement.
- → Union bodies: The Board cooperates with relevant Union bodies to implement the Regulation.
- → codes of practice: The Board collaborates with the AI Office to monitor and evaluate the codes of practice.
- ← National competent authorities: National competent authorities coordinate their activities and cooperate within the framework of the Board.
- → Member States: The Board operates in accordance with the rules adopted by the Member States.
- → AI Office: The AI Office is responsible for preparing the agenda and providing secretariat support for the Board.
- → Regulation (EU) 2019/1020: The Board's activities are governed by Regulation (EU) 2019/1020.
- → Article 30: The Board's standing sub-group for market surveillance acts in accordance with Article 30 of Regulation (EU) 2019/1020.
- → Article 66: Article 66 specifies the tasks of the Board.
- ← Commission: The Commission transmits information, including details about fines, to the Board for discussion and potential recommendations.
- ← AI Office: The AI Office informs the Board of any measures taken in response to alerts.
- ← Commission: The Commission takes into account the positions and findings of the Board during evaluations.
- → Commission: The Board provides the Commission with information upon request for evaluations.
border control authorities
Agencies that manage the entry and exit of individuals at national borders, ensuring compliance with immigration laws.
- ← Regulation: The Regulation provides rules for border control authorities regarding identity verification processes.
border control management
An area where high-risk AI systems are applied to manage border control processes.
- ← high-risk AI systems: High-risk AI systems are applied in the modality of border control management.
CE marking
CE marking certifies that a product complies with EU safety, health, and environmental protection standards for sale within the European Economic Area.
- ← Regulation: The Regulation requires high-risk AI systems to bear the CE marking to indicate conformity.
- → AI system: CE marking lays down rules for indicating conformity of AI systems with regulatory requirements.
- ← high-risk AI systems: High-risk AI systems must have CE marking to indicate compliance with EU regulations.
- ← Regulation 2024/1689: Regulation 2024/1689 requires that the AI system bears the CE marking.
- ← Regulation (EC) No 765/2008: Regulation (EC) No 765/2008 provides the principles governing the CE marking.
- → high-risk AI systems: CE marking requires documentation to be affixed visibly and legibly for high-risk AI systems.
- → Article 43: The CE marking is associated with the conformity assessment procedures outlined in Article 43.
CE marking
A certification mark indicating that an AI system complies with EU safety, health, and environmental standards as per applicable legislation.
- ← Regulation: The Regulation requires high-risk AI systems to bear the CE marking to indicate conformity.
- → AI system: CE marking lays down rules for indicating conformity of AI systems with regulatory requirements.
- ← high-risk AI systems: High-risk AI systems must have CE marking to indicate compliance with EU regulations.
- ← Regulation 2024/1689: Regulation 2024/1689 requires that the AI system bears the CE marking.
- ← Regulation (EC) No 765/2008: Regulation (EC) No 765/2008 provides the principles governing the CE marking.
- → high-risk AI systems: CE marking requires documentation to be affixed visibly and legibly for high-risk AI systems.
- → Article 43: The CE marking is associated with the conformity assessment procedures outlined in Article 43.
CEN
The European Committee for Standardization, a permanent member of the advisory forum contributing to the Regulation's implementation.
CENELEC
The European Committee for Electrotechnical Standardization, involved in standardization efforts related to the Regulation and a permanent member of the advisory forum.
- ← advisory forum: CENELEC is a permanent member of the advisory forum.
certificates
Documents issued by notified bodies to confirm compliance with regulatory standards.
- ← notifying authority: The notifying authority requires the suspension or withdrawal of unduly issued certificates.
- → national competent authorities: Providers must provide relevant information about certificates to the national competent authorities.
- ← notifying authority: The notifying authority confirms the status of certificates affected by suspension or restriction.
- → notifying authority: Certificates require documentation and confirmation from the notifying authority regarding their status.
certificates
Documents issued by notified bodies that validate compliance with AI system regulations and can be suspended or withdrawn under specific circumstances.
- ← notifying authority: The notifying authority requires the suspension or withdrawal of unduly issued certificates.
- → national competent authorities: Providers must provide relevant information about certificates to the national competent authorities.
- ← notifying authority: The notifying authority confirms the status of certificates affected by suspension or restriction.
- → notifying authority: Certificates require documentation and confirmation from the notifying authority regarding their status.
Chapter 2 of Title V TEU
A section of the Treaty on European Union that addresses the common Union defense policy.
- → Member States: This chapter addresses the common Union defense policy that Member States must adhere to.
Chapter III, Section 2
This section outlines specific requirements for high-risk AI systems within Regulation (EU) 2024/1689.
- ← AI Office: The AI Office proposes monitoring compliance of AI systems based on the requirements outlined in Chapter III, Section 2.
- ← AI system: High-risk AI systems must comply with the requirements set out in Chapter III, Section 2, including validation and testing procedures.
- ← Regulation (EU) 2024/1689: Regulation (EU) 2024/1689 includes specific safeguards and requirements outlined in Chapter III, Section 2.
- ← Regulation (EU) 2024/1689: Chapter III, Section 2 of Regulation (EU) 2024/1689 outlines specific requirements for AI systems.
- ← Commission: The Commission evaluates AI systems in accordance with the requirements set out in Chapter III, Section 2.
- ← notified body: The notified body assesses the AI system based on the requirements set out in Chapter III, Section 2.
Chapter III, Section 2
A section within Regulation (EU) 2024/1689 that outlines requirements for AI systems.
- ← AI Office: The AI Office proposes monitoring compliance of AI systems based on the requirements outlined in Chapter III, Section 2.
- ← AI system: High-risk AI systems must comply with the requirements set out in Chapter III, Section 2, including validation and testing procedures.
- ← Regulation (EU) 2024/1689: Regulation (EU) 2024/1689 includes specific safeguards and requirements outlined in Chapter III, Section 2.
- ← Regulation (EU) 2024/1689: Chapter III, Section 2 of Regulation (EU) 2024/1689 outlines specific requirements for AI systems.
- ← Commission: The Commission evaluates AI systems in accordance with the requirements set out in Chapter III, Section 2.
- ← notified body: The notified body assesses the AI system based on the requirements set out in Chapter III, Section 2.
Chapter III, Section 2
A section within Regulation (EU) 2024/1689 that outlines specific requirements and oversight measures for AI systems.
- ← AI Office: The AI Office proposes monitoring compliance of AI systems based on the requirements outlined in Chapter III, Section 2.
- ← AI system: High-risk AI systems must comply with the requirements set out in Chapter III, Section 2, including validation and testing procedures.
- ← Regulation (EU) 2024/1689: Regulation (EU) 2024/1689 includes specific safeguards and requirements outlined in Chapter III, Section 2.
- ← Regulation (EU) 2024/1689: Chapter III, Section 2 of Regulation (EU) 2024/1689 outlines specific requirements for AI systems.
- ← Commission: The Commission evaluates AI systems in accordance with the requirements set out in Chapter III, Section 2.
- ← notified body: The notified body assesses the AI system based on the requirements set out in Chapter III, Section 2.
Chapter III, Section 2
A specific section of regulatory text that outlines requirements for AI systems, including compliance, validation, and testing procedures.
- ← AI Office: The AI Office proposes monitoring compliance of AI systems based on the requirements outlined in Chapter III, Section 2.
- ← AI system: High-risk AI systems must comply with the requirements set out in Chapter III, Section 2, including validation and testing procedures.
- ← Regulation (EU) 2024/1689: Regulation (EU) 2024/1689 includes specific safeguards and requirements outlined in Chapter III, Section 2.
- ← Regulation (EU) 2024/1689: Chapter III, Section 2 of Regulation (EU) 2024/1689 outlines specific requirements for AI systems.
- ← Commission: The Commission evaluates AI systems in accordance with the requirements set out in Chapter III, Section 2.
- ← notified body: The notified body assesses the AI system based on the requirements set out in Chapter III, Section 2.
Chapter V
A chapter within the regulation that includes obligations related to conformity assessment.
- ← Article 40: Article 40 also acts in accordance with obligations set out in Chapter V of the regulation.
Chapter VI of Regulation (EU) 2019/1020
A chapter that provides procedures applicable to market surveillance authorities.
Charter
The Charter of Fundamental Rights of the European Union enshrines the fundamental rights and freedoms of EU citizens.
- ← AI: AI should respect the fundamental rights and freedoms outlined in the Charter.
- ← Treaties: The Treaties provide the legal basis for the Charter of Fundamental Rights.
- → Union values: The Charter includes fundamental rights that are part of the Union values.
- → fundamental rights: The Charter outlines the fundamental rights that must be protected in the context of AI systems.
- → transparency obligation: The transparency obligation must align with the rights guaranteed in the Charter.
Charter
The charter is a document that enshrines fundamental rights and freedoms, including non-discrimination, data protection, and privacy, particularly in the context of AI systems.
- ← AI: AI should respect the fundamental rights and freedoms outlined in the Charter.
- ← Treaties: The Treaties provide the legal basis for the Charter of Fundamental Rights.
- → Union values: The Charter includes fundamental rights that are part of the Union values.
- → fundamental rights: The Charter outlines the fundamental rights that must be protected in the context of AI systems.
- → transparency obligation: The transparency obligation must align with the rights guaranteed in the Charter.
Charter of Fundamental Rights of the European Union
A document that enshrines fundamental rights such as democracy, the rule of law, and environmental protection within the European Union.
- ← Regulation: The Regulation is applied in accordance with the values enshrined in the Charter.
- ← AI systems: AI systems must be developed and used in accordance with the fundamental rights obligations outlined in the Charter.
Charter of Fundamental Rights of the European Union
A document that enshrines fundamental rights and freedoms in the EU, including health and safety.
- ← Regulation: The Regulation is applied in accordance with the values enshrined in the Charter.
- ← AI systems: AI systems must be developed and used in accordance with the fundamental rights obligations outlined in the Charter.
civil society organisations
Non-governmental organizations that represent various interests and advocate for the rights of individuals and communities.
- ← impact assessment: The impact assessment process may involve civil society organisations to ensure comprehensive evaluation and stakeholder engagement.
civilian purposes
Non-military uses of AI systems, such as humanitarian efforts or law enforcement.
- ← AI systems: AI systems can be used for civilian purposes, which are non-military in nature.
- ← AI system: AI systems intended for civilian purposes are subject to the Regulation.
civilian purposes
Uses of AI systems that fall within the scope of the Regulation, as opposed to military or defense uses.
- ← AI systems: AI systems can be used for civilian purposes, which are non-military in nature.
- ← AI system: AI systems intended for civilian purposes are subject to the Regulation.
closed circuit television cameras
Devices used to capture video footage for surveillance and identification purposes.
- ← video footage: Video footage is generated by closed circuit television cameras for identification purposes.
codes of conduct
Codes of conduct are frameworks and guidelines developed under regulation to ensure ethical practices in the design and use of AI models.
- ← ethical principles: The ethical principles should inform the drafting of codes of conduct for AI systems.
- ← AI Office: The AI Office encourages the drawing up of codes of conduct for the voluntary application of AI requirements.
- ← AI Office: The AI Office facilitates the development of codes of conduct for AI systems.
- ← Member States: Member States assist in the drawing up of codes of conduct for AI systems.
- → Union ethical guidelines for trustworthy AI: Codes of conduct may incorporate elements from the Union ethical guidelines for trustworthy AI.
- → vulnerable persons: Codes of conduct aim to assess and prevent the negative impact of AI systems on vulnerable persons.
- → start-ups: Codes of conduct may also consider the needs of start-ups in their development.
- → environmental sustainability: Codes of conduct may include parameters related to environmental sustainability.
- → AI literacy: Codes of conduct may promote AI literacy among users and developers.
- → inclusive and diverse design: Codes of conduct may facilitate an inclusive and diverse design of AI systems.
codes of practice
Guidelines outlining the obligations for providers of general-purpose AI models to ensure compliance with regulations and manage systemic risks.
- ← AI Office: The AI Office proposes the establishment and adaptation of codes of practice to facilitate compliance with transparency obligations and ensure proper application of regulations for AI models.
- → general-purpose AI models: Codes of practice establish guidelines for compliance for providers of general-purpose AI models.
- ← AI Office: The AI Office is responsible for approving codes of practice to ensure they meet compliance standards.
- → systemic risks: Codes of practice aim to improve the management and assessment of systemic risks associated with AI.
- ← implementation acts: Implementation acts may propose the approval of codes of practice if they are not finalized or deemed adequate.
- ← Article 56 (6): The procedure for adopting implementing acts is outlined in Article 56 (6) of the regulation.
- → Article 53: The codes of practice must cover the obligations provided for in Article 53.
- → Article 55: The codes of practice must also include the obligations outlined in Article 55.
- ← systemic risks: The assessment and management of systemic risks must be documented as part of the codes of practice.
- ← AI Office: The AI Office aims to ensure that the codes of practice are effective and meet the needs of all stakeholders.
- ← Board: The Board collaborates with the AI Office to monitor and evaluate the codes of practice.
- → Articles 53 and 55: The codes of practice must cover the obligations outlined in Articles 53 and 55.
- → key performance indicators: The codes of practice require the establishment of key performance indicators for measuring success.
- → 2 May 2025: Codes of practice must be ready by 2 May 2025.
codes of practice
Codes of practice serve as guidelines for AI model providers to ensure responsible use and compliance with obligations related to systemic risks.
- ← AI Office: The AI Office proposes the establishment and adaptation of codes of practice to facilitate compliance with transparency obligations and ensure proper application of regulations for AI models.
- → general-purpose AI models: Codes of practice establish guidelines for compliance for providers of general-purpose AI models.
- ← AI Office: The AI Office is responsible for approving codes of practice to ensure they meet compliance standards.
- → systemic risks: Codes of practice aim to improve the management and assessment of systemic risks associated with AI.
- ← implementation acts: Implementation acts may propose the approval of codes of practice if they are not finalized or deemed adequate.
- ← Article 56 (6): The procedure for adopting implementing acts is outlined in Article 56 (6) of the regulation.
- → Article 53: The codes of practice must cover the obligations provided for in Article 53.
- → Article 55: The codes of practice must also include the obligations outlined in Article 55.
- ← systemic risks: The assessment and management of systemic risks must be documented as part of the codes of practice.
- ← AI Office: The AI Office aims to ensure that the codes of practice are effective and meet the needs of all stakeholders.
- ← Board: The Board collaborates with the AI Office to monitor and evaluate the codes of practice.
- → Articles 53 and 55: The codes of practice must cover the obligations outlined in Articles 53 and 55.
- → key performance indicators: The codes of practice require the establishment of key performance indicators for measuring success.
- → 2 May 2025: Codes of practice must be ready by 2 May 2025.
Commission
The European Commission is the executive body of the EU responsible for proposing legislation, ensuring compliance with EU laws, and overseeing the regulation of AI systems.
- ← European Artificial Intelligence Board: The Board supports the Commission in promoting AI literacy tools.
- ← Market Surveillance Authority: The Market Surveillance Authority submits annual reports, informs about authorizations, and transmits evaluation results and non-compliance measures regarding biometric identification systems to the Commission.
- ← National Data Protection Authority: The National Data Protection Authority submits an annual report on the use of biometric identification systems to the Commission.
- → high-risk AI systems: The Commission is responsible for proposing amendments and regulations regarding the classification and use of high-risk AI systems.
- → Board: The Commission consults the Board to provide guidelines for the implementation of AI system regulations.
- → metrology and benchmarking authorities: The Commission collaborates with metrology and benchmarking authorities to develop benchmarks for AI systems.
- → international partners: The Commission collaborates with international partners on metrology and measurement indicators related to AI.
- → high-risk AI system: The Commission proposes voluntary model contractual terms for cooperation along the AI value chain.
- → Regulation: The Commission is empowered to amend the annexes of the Regulation.
- → general-purpose AI model: The Commission may propose to designate a general-purpose AI model as having systemic risks based on assessments.
- ← general-purpose AI models: Providers of general-purpose AI models must report incidents to the Commission.
- → notified bodies: The Commission oversees the notification process for notified bodies.
- ← World Trade Organization Agreement on Technical Barriers to Trade: The agreement encourages the Commission to facilitate mutual recognition of conformity assessments.
- → mutual recognition agreements: The Commission should actively explore and pursue mutual recognition agreements with third countries.
- → EU database: The Commission is responsible for establishing and managing the EU database for high-risk AI systems.
- → EU Database: The Commission manages and controls the EU database in accordance with Regulation (EU) 2018/1725.
- → Member States: The Commission should work with Member States to lower certification and compliance costs for SMEs.
- → microenterprises: The Commission proposes guidelines for microenterprises to establish a quality management system.
- → testing and experimentation facilities: The Commission facilitates access to testing and experimentation facilities for accredited bodies.
- → standing subgroup for market surveillance: The Commission supports the activities of the standing subgroup by undertaking market evaluations.
- → general-purpose AI systems: The Commission aims to improve the supervision and enforcement of obligations on providers of general-purpose AI models.
- → Regulation (EU) No 182/2011: The Commission exercises implementing powers in accordance with Regulation (EU) No 182/2011.
- → European Parliament: The Commission submits evaluations, assessments, and reports related to the Regulation to the European Parliament.
- → Council: The Commission reports evaluations and assessments related to the Regulation to the Council.
- → 2 August 2029: The Commission must evaluate and review the Regulation by 2 August 2029.
- → 2 August 2028: The Commission is required to evaluate and report on potential amendments to high-risk areas by 2 August 2028.
- ← Regulation (EU) No 182/2011: This regulation confers implementing powers on the Commission.
- ← Member State: Member States must notify the Commission of the rules regarding the use of biometric identification systems.
- ← Member States: Member States must submit annual reports on biometric identification systems and the status of their national competent authorities to the Commission.
- → annual reports: The Commission publishes annual reports based on the aggregated data from Member States regarding biometric identification systems.
- → 2 February 2026: The Commission is required to provide guidelines and adopt an implementing act by 2 February 2026.
- → small and microenterprises: Proposes a simplified technical documentation form for small and microenterprises.
- → Annex IV: The Commission proposes to establish a simplified technical documentation form as outlined in Annex IV.
- → Article 97: The Commission acts in accordance with Article 97 to amend Annex IV and adopt necessary delegated acts.
- ← High-risk AI systems: High-risk AI systems must comply with the regulations and guidelines set forth by the Commission.
- → benchmarks: The Commission encourages the development of benchmarks for measuring the performance of high-risk AI systems.
- ← notifying authorities: Notifying authorities must notify the Commission of conformity assessment bodies that meet the requirements.
- → electronic notification tool: The Commission develops and manages the electronic notification tool for conformity assessment bodies.
- → Member States: The Commission communicates its decisions regarding the authorization of notified bodies to Member States.
- → notified bodies: The Commission transmits identification numbers and lists to notified bodies.
- ← notifying authority: The notifying authority informs the Commission about the status of the notified body.
- → notifying authority: The Commission requests relevant information from the notifying authority.
- → notified body: The Commission ensures that notified bodies meet the requirements for their notification.
- → high-risk AI systems: The Commission coordinates conformity assessment procedures for high-risk AI systems.
- → knowledge and best practices: The Commission facilitates the exchange of knowledge and best practices among notifying authorities.
- → European standardisation organisations: The Commission transmits standardisation requests to European standardisation organisations to ensure compliance with regulations.
- → AI systems: The Commission aims to improve the resource performance of AI systems through standardisation requests.
- → Article 67: The Commission shall consult the advisory forum as referred to in Article 67 when drafting common specifications.
- → Article 22: The Commission must inform the committee referred to in Article 22 before preparing a draft implementing act.
- ← Member State: A Member State must inform the Commission if it believes that a common specification does not meet the required standards.
- → common specifications: The Commission may amend the common specifications based on the information received from Member States.
- → Annexes VI and VII: The Commission is empowered to amend Annexes VI and VII.
- → Annex III: The Commission amends regulations concerning high-risk AI systems as specified in Annex III.
- → Union law: The Commission evaluates authorizations based on compliance with Union law.
- → Member State: The Commission notifies the relevant Member State of its decisions and findings regarding AI systems.
- → EU database: The Commission has an opinion on the access to the restricted sections of the EU database.
- → Article 56 (6): The Commission acts in accordance with Article 56 (6) to adopt implementing acts for codes of practice.
- → Article 98(2): The Commission acts in accordance with Article 98(2) for implementing obligations regarding AI models.
- → Article 97: The Commission proposes to adopt delegated acts in accordance with Article 97 to amend thresholds and benchmarks.
- ← Article 52: Article 52 outlines the procedure for providers to notify the Commission about general-purpose AI models.
- → general-purpose AI model: The Commission designates a general-purpose AI model as presenting systemic risks based on specific criteria.
- → Annex XIII: The Commission is empowered to amend Annex XIII to update the criteria for systemic risks.
- ← providers: Providers may request the Commission to reassess the designation of their AI model after a specified period.
- → list of general-purpose AI models: The Commission ensures that a list of designated general-purpose AI models with systemic risks is published and updated.
- → Article 97(2): The Commission acts in accordance with Article 97(2) to amend annexes based on technological developments.
- → Annex XI: The Commission requires that technical documentation specified in Annex XI be fulfilled by providers.
- ← providers of general-purpose AI models with systemic risk: Providers must demonstrate compliance to the Commission for assessment.
- → National competent authorities: The Commission coordinates with national competent authorities regarding AI regulatory sandboxes.
- → AI regulatory sandbox: The Commission develops a dedicated interface for stakeholders to interact with AI regulatory sandboxes.
- ← Advisory Forum: The Advisory Forum provides technical expertise and advice to the Commission.
- → Regulation 2024/1689: The Commission acts in accordance with Regulation 2024/1689 to implement AI governance.
- → scientific panel: The Commission proposes the establishment of a scientific panel to support enforcement activities.
- → scientific panel: The Commission selects experts for the scientific panel based on their expertise in AI.
- → Member States: The Commission facilitates access to experts for Member States as needed.
- → national competent authorities: The Commission facilitates the exchange of experience between national competent authorities.
- → Board: The Commission transmits information, including details about fines, to the Board for discussion and potential recommendations.
- → EU database for high-risk AI systems: The Commission proposes to set up and maintain the EU database for high-risk AI systems.
- → EU database: The Commission controls the EU database and ensures it meets accessibility requirements.
- → 2 August 2025: The Commission is required to issue guidance by the specified date.
- ← national competent authority: National competent authorities must notify the Commission of serious incidents.
- ← market surveillance authorities: Market surveillance authorities report annually to the Commission about market surveillance activities.
- ← Market surveillance authorities: Proposes joint activities including investigations to promote compliance.
- ← national competent authorities: National competent authorities exchange information with the Commission regarding AI systems.
- → Article 5: The Commission evaluates national measures based on the prohibitions outlined in Article 5.
- → Articles 40 and 41: The Commission applies procedures related to shortcomings in harmonised standards as referred to in Articles 40 and 41.
- ← Regulation (EU) No 1025/2012: The procedures outlined in Regulation (EU) No 1025/2012 may be applied by the Commission in response to justified national measures.
- ← Member State: Member States provide their findings and opinions to the Commission regarding AI systems.
- ← Regulation (EU) 2019/1020: The Commission acts in accordance with the provisions set out in Regulation (EU) 2019/1020.
- → AI Office: The Commission entrusts the AI Office with the implementation of supervision and enforcement tasks.
- ← Market Surveillance Authorities: Market surveillance authorities may request the Commission to exercise its powers.
- → AI Office: The Commission may exercise powers and inform the AI Office about assessments.
- → general-purpose AI model: The Commission may request documentation from the provider of the general-purpose AI model.
- → Article 98: The Commission adopts implementing acts in accordance with the examination procedure outlined in Article 98.
- → Article 53: The Commission may request providers to take measures to comply with obligations set out in Article 53.
- → Article 54: The Commission may request providers to take measures to comply with obligations set out in Article 54.
- ← European Parliament: The European Parliament receives notifications from the Commission regarding delegated acts.
- ← Council: The Council receives notifications from the Commission regarding delegated acts.
- → Interinstitutional Agreement of 13 April 2016: The Commission consults experts in accordance with the principles laid down in the Interinstitutional Agreement.
- → Official Journal of the European Union: The Commission's decisions take effect upon publication in the Official Journal.
- → European Parliament: The Commission notifies the European Parliament of adopted delegated acts.
- → Council: The Commission notifies the Council of adopted delegated acts.
- → Regulation (EU) No 182/2011: The Commission issues guidelines pursuant to Regulation (EU) No 182/2011.
- → general-purpose AI models: The Commission lays down rules for the compliance of providers of general-purpose AI models.
- → Article 112: The Commission is required to assess the need for amendments as outlined in Article 112.
- ← Article 50: Article 50 requires the Commission to evaluate AI systems needing additional transparency measures.
- → AI Office: The Commission shall evaluate the functioning of the AI Office by 2 August 2028.
- → Regulation 2024/1689: The Commission proposes amendments to Regulation 2024/1689 based on technological developments.
- → Board: The Commission takes into account the positions and findings of the Board during evaluations.
- → Chapter III, Section 2: The Commission evaluates AI systems in accordance with the requirements set out in Chapter III, Section 2.
- → environmental sustainability: The Commission aims to improve the environmental sustainability of AI systems through evaluations.
- ← Board: The Board provides the Commission with information upon request for evaluations.
- → European Economic and Social Committee: The Commission will inform the European Economic and Social Committee about the assessment.
Commission Decision of 24 January 2024
The decision that outlines the establishment of the AI Office.
- → AI Office: The decision that established the AI Office was made on this date.
Commission Decision of 24.1.2024
A decision establishing the European Artificial Intelligence Office.
- → AI Office: The Commission Decision of 24.1.2024 establishes the AI Office.
Commission Recommendation 2003/361/EC
A regulation that defines the criteria for small and medium-sized enterprises (SMEs) within the European Union.
- → SMEs: The regulation defines the criteria that affect the classification and support of SMEs.
Commission Work Programme 2021
A document that refers to the involvement of employees and service providers in work-related contractual relationships.
- → high-risk AI systems: The document proposes meaningful involvement of employees in AI systems affecting work-related relationships.
common rules for AI regulatory sandboxes
Set of guidelines established to ensure uniform implementation of AI regulatory sandboxes across the Union.
- → AI regulatory sandbox: Common rules are established to ensure uniform implementation of AI regulatory sandboxes.
common specification
A set of technical specifications defined in Article 2, point (4) of Regulation (EU) No 1025/2012 for compliance with certain requirements.
common specifications
Common specifications provide fallback guidelines for compliance when harmonised standards are unavailable or inadequate.
- ← Regulation (EU) No 1025/2012: The regulation includes provisions for common specifications as a fallback when harmonised standards are inadequate.
- ← High-risk AI systems: High-risk AI systems must comply with the common specifications set out in the regulation.
- ← general-purpose AI models: General-purpose AI models must also comply with the common specifications set out in the regulation.
- ← Commission: The Commission may amend the common specifications based on the information received from Member States.
- → compliance: Common specifications aim to improve compliance when harmonised standards are not available.
common specifications
Regulatory requirements that AI systems must meet to ensure safety and compliance.
- ← Regulation (EU) No 1025/2012: The regulation includes provisions for common specifications as a fallback when harmonised standards are inadequate.
- ← High-risk AI systems: High-risk AI systems must comply with the common specifications set out in the regulation.
- ← general-purpose AI models: General-purpose AI models must also comply with the common specifications set out in the regulation.
- ← Commission: The Commission may amend the common specifications based on the information received from Member States.
- → compliance: Common specifications aim to improve compliance when harmonised standards are not available.
competent authorities
Regulatory bodies responsible for overseeing compliance and safety of AI systems during their development and implementation.
- ← Regulation (EU) 2024/1689: The regulation requires cooperation with competent authorities for compliance.
- ← Regulation: The Regulation requires competent authorities to oversee the testing and development of AI systems.
- ← EU database: The EU database is used by competent authorities to register testing activities.
- → AI project: The competent authorities publish summaries of AI projects developed in the sandbox.
- ← provider: The provider must cooperate with competent authorities during investigations of serious incidents.
competent authority
A competent authority oversees compliance and enforcement of regulations related to high-risk AI systems.
- → high-risk AI system: The competent authority can request documentation related to the high-risk AI system, including access to logs.
- → Article 78: The competent authority must treat information obtained in accordance with the confidentiality obligations set out in Article 78.
- → high-risk AI system: The competent authority cooperates with the provider in ensuring compliance and mitigating risks.
- ← distributors: Distributors must provide information to competent authorities upon request.
- → AI regulatory sandbox: The competent authority provides guidance, supervision, and support within the AI regulatory sandbox.
- → market surveillance authorities: The competent authority provides exit reports to market surveillance authorities to assist in conformity assessment.
competent public authorities
Authorities designated by law to manage migration, asylum, and border control, utilizing AI systems in their operations.
- → natural persons: Competent public authorities require documentation from natural persons applying for asylum, visa, and residence permits.
- ← AI systems: AI systems are utilized by competent public authorities for various assessments, including risk evaluations and profiling.
- → natural persons: The actions of competent public authorities in assessing natural persons can impact the market for services related to migration and asylum.
- ← AI systems: AI systems are intended to be used by or on behalf of competent public authorities.
Computation
The amount of computational resources used for training AI models, often measured in floating point operations.
computational resources
The resources required to train the AI model, including the number of floating point operations and training time.
computational resources
Resources such as processing power and memory used to train the AI model.
conformity assessment body
An organization that assesses the conformity of products or services with specified requirements.
- → Article 31: Article 31 lays down the requirements that the conformity assessment body must fulfill.
- → accreditation certificate: The conformity assessment body must provide an accreditation certificate or equivalent documentation.
core function of the State
Fundamental responsibilities and duties of a government to ensure the safety and welfare of its citizens.
- ← identity checks: Identity checks are essential for maintaining the core functions of the State, including public safety.
Council
The Council of the European Union, representing member state governments and collaborating with the European Parliament to create and adopt legislation.
- ← Commission: The Commission reports evaluations and assessments related to the Regulation to the Council.
- → Commission: The Council receives notifications from the Commission regarding delegated acts.
- ← Commission: The Commission notifies the Council of adopted delegated acts.
Council Directive 84/450/EEC
A directive that was amended by Directive 2005/29/EC, concerning misleading advertising.
- ← Directive 2005/29/EC: Directive 2005/29/EC amends Council Directive 84/450/EEC regarding unfair commercial practices.
Council Directive 85/374/EEC
A directive concerning liability for defective products, which remains applicable alongside the new regulation.
- ← Union law: Union law includes safeguards for consumers that remain unaffected by the new regulation.
Council Directive 87/357/EEC
A directive that was repealed by Regulation (EU) 2023/988, concerning the safety of certain products.
Council Directives 89/686/EEC and 93/15/EEC
Directives that are amended by Regulation (EU) No 1025/2012, related to safety and compliance in various sectors.
Council Framework Decision 2002/584/JHA
This framework decision outlines criminal offenses relevant to law enforcement and establishes procedures for the European arrest warrant among Member States.
Council Framework Decision 2008/977/JHA
A framework decision concerning the protection of personal data processed in the framework of police and judicial cooperation in criminal matters.
Council of 25 November 2020
The Council of the European Union, which adopted a regulation on representative actions for consumer protection.
Council of the European Union
The Council of the European Union represents member states' governments and collaborates with the European Parliament in the legislative process.
Council Regulation (EU) No 1024/2013
A regulation that establishes the Single Supervisory Mechanism, conferring specific supervisory tasks to the European Central Bank for credit institutions.
- ← Directive 2013/36/EU: Directive 2013/36/EU acts in accordance with the provisions established by Council Regulation (EU) No 1024/2013.
- → European Central Bank: Council Regulation (EU) No 1024/2013 confers specific tasks on the European Central Bank.
Court of Justice of the European Union
The highest court in the EU, responsible for ensuring uniform interpretation and application of EU law.
- ← Regulation: Decisions taken under this Regulation are subject to review by the Court of Justice.
- ← Regulation (EU) 2024/1689: The Court of Justice reviews decisions made under Regulation (EU) 2024/1689.
credit score evaluation
AI systems used to assess the creditworthiness of individuals, classified as high-risk due to their impact on access to financial resources.
- → natural persons: AI systems evaluating credit scores affect natural persons' access to financial resources.
criteria for designation
The set of standards outlined in an annex to the regulation for classifying AI models with systemic risks.
- → general-purpose AI model: The criteria for designation includes safeguards for assessing systemic risks of general-purpose AI models.
Critical digital infrastructure
Essential services and systems that support the functioning of society, such as water, gas, heating, and electricity supply.
critical infrastructure
Essential systems and assets that are vital for the functioning of a society and economy.
critical infrastructure
Essential systems such as water, gas, heating, and electricity that are vital for the health and safety of persons and the functioning of society.
critical infrastructure
An area where high-risk AI systems are utilized, requiring registration at the national level.
Critical infrastructure
AI systems used as safety components in the management and operation of critical digital infrastructure.
critical products
Products with digital elements that are deemed essential and require a high level of assurance.
critical thinking
An essential competence for learners to analyze and evaluate information in educational contexts.
- → AI systems: Critical thinking is a competence that AI systems help develop in learners.
cryptographic methods
Techniques used to ensure the provenance and authenticity of content through cryptography.
- ← AI systems: AI systems should implement cryptographic methods for content provenance.
cyber resilience
The ability of an AI system to withstand and recover from cyber threats.
- ← Regulation: The regulation includes safeguards to ensure the cyber resilience of AI systems.
cybersecurity
A set of measures and controls aimed at protecting AI systems from cyberattacks and ensuring their resilience against malicious activities.
- ← AI system: AI systems must comply with cybersecurity measures to ensure their resilience against risks.
- ← AI regulatory sandboxes: AI regulatory sandboxes assess cybersecurity measures to protect AI systems from potential threats.
cybersecurity
Cybersecurity encompasses measures and practices designed to protect systems, networks, and data from cyber threats and attacks.
- ← AI system: AI systems must comply with cybersecurity measures to ensure their resilience against risks.
- ← AI regulatory sandboxes: AI regulatory sandboxes assess cybersecurity measures to protect AI systems from potential threats.
cybersecurity measures
These technical measures are designed to protect high-risk AI systems from unauthorized alterations and cyber threats.
- ← High-risk AI systems: High-risk AI systems implement cybersecurity measures to protect against unauthorized access and alterations.
- ← AI system: The AI system includes cybersecurity measures as safeguards against potential threats.
cybersecurity protection
Measures to ensure the security of AI models and their infrastructure against systemic risks.
- → general-purpose AI models: Cybersecurity protection includes safeguards for general-purpose AI models against systemic risks.
cybersecurity scheme
A framework under which high-risk AI systems can be certified for compliance with cybersecurity requirements.
- ← Regulation (EU) 2019/881: Regulation (EU) 2019/881 includes provisions for a cybersecurity scheme for high-risk AI systems.
data
Large amounts of information used to train AI models through various learning methods.
data
The information used for training, testing, and validating the AI model, including its type and provenance.
Data Act
The directive that Regulation (EU) 2023/2854 amends, concerning fair access to and use of data.
Data and data governance
An article that discusses the requirements for data sets used in the development of high-risk AI systems.
data collections
Aggregated sets of data that may be used in the training of AI models, which can include both private and public databases.
- ← general-purpose AI models: General-purpose AI models utilize various data collections for training, which must be disclosed to ensure transparency.
data governance
The framework that ensures compliance with data requirements, including integrity and validation of data sets.
- → AI system: Data governance establishes rules that must be followed for the compliance of AI systems.
Data Governance Act
The directive that Regulation (EU) 2022/868 amends, focusing on data governance in the EU.
data management systems
Systems and procedures for managing data related to high-risk AI systems, including acquisition, collection, and analysis.
- → high-risk AI system: Data management systems are necessary for the operation and compliance of high-risk AI systems.
data protection and privacy
Fundamental rights that may be undermined by AI systems monitoring performance and behavior.
Data set
A collection of data used for training, testing, and validation of AI models.
data sets
Collections of high-quality and relevant data used for training, validation, and testing AI systems, essential for their effective performance.
- ← high-risk AI system: High-risk AI systems require high-quality data sets for effective training and validation.
- → Regulation (EU) 2016/679: Data governance practices for data sets must comply with the provisions of Regulation (EU) 2016/679.
- → high-risk AI system: Data sets are required for the development and testing of high-risk AI systems.
- → vulnerable groups: Data sets should include safeguards to protect vulnerable groups from bias and discrimination.
- ← European Digital Innovation Hubs: These hubs provide access to high-quality data sets necessary for the development of AI systems.
data sheets
Documentation that details the datasets used in AI systems, aiding in information sharing and trust.
- → AI system: Data sheets are suggested as a means to provide essential information about datasets used in AI systems.
data used for training
The dataset utilized for training, testing, and validating the general-purpose AI model.
date of release
The date when the general-purpose AI model is made available for use.
Decision No 1247/2002/EC
A decision related to the processing of personal data and privacy in the context of the European Union.
Decision No 768/2008/EC
This decision establishes harmonised rules applicable across sectors, providing a common framework for product marketing and conformity assessment.
- → personal data: The decision provides a framework that includes considerations for the marketing of products involving personal data.
deep fake
AI-generated or manipulated content that misleadingly resembles real persons, objects, or events.
- → widespread infringement: Deep fakes can lead to widespread infringement of laws protecting individual interests.
- → personal data: Deployers must disclose when content has been artificially generated or manipulated.
deep fakes
Content that has been artificially created or manipulated to resemble existing persons, objects, or events, potentially misleading viewers.
- ← AI system: AI systems that generate deep fakes must document and disclose the artificial nature of the content.
- ← transparency obligation: The transparency obligation aims to improve the disclosure of AI-generated content to maintain authenticity.
defence rights of suspects
Legal rights that protect individuals under investigation, particularly regarding the use of AI tools.
- ← AI tools: The use of AI tools can impact the defence rights of suspects, particularly in obtaining information.
deployer
The deployer is any individual or entity, including public authorities, that utilizes an AI system under their authority, excluding personal non-professional activities.
- ← AI systems: The use of AI systems by deployers may affect persons other than the deployer.
- ← AI system: The deployer uses the AI system under its authority.
- → high-risk AI systems: The deployer implements high-risk AI systems and must ensure that human oversight is maintained.
- → high-risk AI system: The deployer monitors the operation of the high-risk AI system based on the provider's instructions.
- → provider: The deployer informs the provider about risks associated with the high-risk AI system.
- → market surveillance authority: The deployer must inform the market surveillance authority about serious incidents and the results of their assessments related to the AI system.
- ← Union financial services law: The Union financial services law sets requirements for the internal governance of financial institutions acting as deployers.
- → fundamental rights impact assessments: The deployer may rely on previously conducted fundamental rights impact assessments.
- → EU database: Deployers enter data into the EU database on behalf of public authorities.
- → serious incident: The deployer must report serious incidents when they become aware of them.
deployer
An entity that deploys AI systems and is responsible for reporting serious incidents.
- ← AI systems: The use of AI systems by deployers may affect persons other than the deployer.
- ← AI system: The deployer uses the AI system under its authority.
- → high-risk AI systems: The deployer implements high-risk AI systems and must ensure that human oversight is maintained.
- → high-risk AI system: The deployer monitors the operation of the high-risk AI system based on the provider's instructions.
- → provider: The deployer informs the provider about risks associated with the high-risk AI system.
- → market surveillance authority: The deployer must inform the market surveillance authority about serious incidents and the results of their assessments related to the AI system.
- ← Union financial services law: The Union financial services law sets requirements for the internal governance of financial institutions acting as deployers.
- → fundamental rights impact assessments: The deployer may rely on previously conducted fundamental rights impact assessments.
- → EU database: Deployers enter data into the EU database on behalf of public authorities.
- → serious incident: The deployer must report serious incidents when they become aware of them.
digital CE marking
A certification mark indicating that a product complies with EU safety, health, and environmental protection standards.
- ← high-risk AI systems: The regulation lays down rules for the compliance of high-risk AI systems with the digital CE marking.
Digital Europe Programme
A funding programme by the European Union aimed at enhancing digital skills and infrastructure.
- → this Regulation: The programme aims to enhance digital skills and infrastructure, contributing to the objectives of the Regulation.
- ← AI Office: The AI Office will leverage synergies with the AI testing and experimentation facilities under the Digital Europe Programme.
Digital Europe Programme
A programme aimed at reinforcing the EU's digital capabilities and promoting the digital transformation of the economy and society.
- → this Regulation: The programme aims to enhance digital skills and infrastructure, contributing to the objectives of the Regulation.
- ← AI Office: The AI Office will leverage synergies with the AI testing and experimentation facilities under the Digital Europe Programme.
Digital Services Act
A regulation aimed at establishing a single market for digital services, amending Directive 2000/31/EC.
- → Directive 2000/31/EC: The Digital Services Act amends Directive 2000/31/EC to enhance regulations for digital services.
- ← biometric categorisation: The Digital Services Act lays down rules for the use of biometric categorisation in digital services.
Digital Single Market
A market framework aimed at ensuring the free movement of goods, services, and capital within the European Union.
- ← AI Office: The AI Office aims to strengthen the functioning of the Digital Single Market.
Directive (EU) 2016/2102
A directive concerning the accessibility of public sector websites and mobile applications, establishing requirements that high-risk AI systems must meet.
- ← high-risk AI system: The high-risk AI system must comply with the accessibility requirements set forth in Directive (EU) 2016/2102.
- → public sector bodies: The directive addresses the accessibility requirements for websites and mobile applications of public sector bodies.
- ← high-risk AI system: The high-risk AI system must comply with accessibility requirements set by Directive (EU) 2016/2102.
Directive (EU) 2016/680
This directive provides rules for the protection of personal data processed by competent authorities for law enforcement purposes, enhancing privacy and data security.
- ← Regulation: The Regulation aligns with the protections established by Directive (EU) 2016/680, including safeguards for biometric data processing.
- → Council Framework Decision 2008/977/JHA: Directive (EU) 2016/680 repeals Council Framework Decision 2008/977/JHA.
- → biometric data: Directive (EU) 2016/680 defines biometric data in Article 3, point (13).
- → biometric data: Directive (EU) 2016/680 lays down rules for the processing of biometric data by competent authorities.
- ← Regulation: The Regulation acts in accordance with the rules set by Directive (EU) 2016/680 regarding biometric data processing.
- → Article 10: Directive (EU) 2016/680 includes Article 10, which specifies rules for biometric data processing.
- ← AI system: AI systems must operate in accordance with Directive (EU) 2016/680 for data processing by authorities, particularly in law enforcement.
- → Article 3, point (4): Directive (EU) 2016/680 includes provisions related to personal data processing as outlined in Article 3, point (4).
- → personal data: This directive includes provisions for the protection of personal data in criminal justice contexts.
- ← AI system: AI systems must adhere to the documentation requirements outlined in this directive.
- ← high-risk AI systems: High-risk AI systems used for law enforcement must comply with the obligations set forth in Directive (EU) 2016/680.
- ← Article 13: Article 13 is a specific provision within Directive (EU) 2016/680 that addresses obligations related to personal data.
- ← post-remote biometric identification systems: The use of post-remote biometric identification systems must adhere to the principles outlined in Directive (EU) 2016/680.
- → Article 4 (1) of Directive (EU) 2016/680: Directive (EU) 2016/680 contains Article 4 (1), which lays down key principles for data processing.
- ← AI regulatory sandbox: The AI regulatory sandbox operates under the rules established by Directive (EU) 2016/680.
- ← market surveillance authorities: Market surveillance authorities act in accordance with the powers conferred by Directive (EU) 2016/680.
- ← Regulation (EU) 2016/679: Regulation (EU) 2016/679 amends provisions in Directive (EU) 2016/680 concerning data protection.
- ← personal data: The processing of personal data must comply with Directive (EU) 2016/680.
- → personal data: Provides guidelines for the processing of personal data for law enforcement purposes.
- ← high-risk AI system for post-remote biometric identification: The use of high-risk AI systems must comply with Directive (EU) 2016/680 concerning the processing of biometric data.
- → Article 27: Directive (EU) 2016/680 includes Article 27, which specifies obligations regarding data protection.
- → market surveillance authority: The Directive provides additional safeguards that the market surveillance authority must consider.
- → Market surveillance authorities: Lays down rules for the designation of market surveillance authorities.
- ← Law enforcement authorities: Law enforcement authorities must comply with the regulations set forth in Directive (EU) 2016/680.
- ← OJ L, 12.7.2024: The publication date of the official journal where the directive is recorded.
- ← AI systems: AI systems are intended to be used in compliance with the rules laid down in Directive (EU) 2016/680.
Directive (EU) 2016/797
A directive concerning the interoperability of the rail system within the EU, aimed at enhancing safety and efficiency.
Directive (EU) 2016/943
This directive addresses the protection of undisclosed know-how and business information against unlawful acquisition, use, and disclosure.
- ← Article 78: Article 78 references Directive (EU) 2016/943 regarding confidentiality exceptions.
- → Market Surveillance Authority: The directive includes safeguards for the protection of trade secrets that the market surveillance authority must enforce.
Directive (EU) 2019/1937
A directive focused on the protection of whistleblowers reporting infringements of Union law.
- → Regulation (EU) 2023/988: Directive (EU) 2019/1937 applies to the reporting of infringements of Regulation (EU) 2023/988.
- → this Regulation: The directive amends the regulatory framework regarding the reporting of infringements.
- → persons who report breaches: The directive aims to improve the protection of whistleblowers reporting breaches of Union law.
- → Article 87: Directive (EU) 2019/1937 includes Article 87, which pertains to reporting infringements.
Directive (EU) 2019/790
A directive addressing copyright law and its implications for digital content and AI, particularly concerning text and data mining.
Directive (EU) 2019/882
This directive addresses accessibility requirements for products and services, particularly in the context of AI systems, and aims to protect individuals' vulnerabilities.
- ← AI-enabled manipulative techniques: The directive aims to regulate AI systems that exploit vulnerabilities, including manipulative techniques.
- → European Parliament: The directive is proposed by the European Parliament.
- → Council of the European Union: The directive is proposed by the Council of the European Union.
- ← high-risk AI system: The high-risk AI system must comply with the accessibility requirements set forth in Directive (EU) 2019/882.
- ← EU database: The EU database must comply with the requirements set forth in Directive (EU) 2019/882.
- ← high-risk AI system: The high-risk AI system must comply with accessibility requirements set by Directive (EU) 2019/882.
Directive (EU) 2020/1828
A directive concerning representative actions for consumer protection, amended by the Artificial Intelligence Act.
Directive (EU) 2022/2557
This directive establishes rules for the protection and resilience of critical infrastructure and network security across the EU.
Directive 2000/31/EC
This directive addresses legal aspects of information society services, particularly focusing on electronic commerce and digital services.
Directive 2001/95/EC
A directive that was repealed by Regulation (EU) 2023/988, concerning general product safety.
Directive 2002/14/EC
A directive from the European Parliament and Council that establishes a framework for informing and consulting employees in the European Community.
- → workers: The directive affects the obligations of employers to inform and consult workers regarding AI systems.
- → employees: Directive 2002/14/EC lays down rules for informing and consulting employees in the European Community.
- ← OJ L 80, 23.3.2002: The official journal date for Directive 2002/14/EC.
Directive 2002/58/EC
This directive addresses the protection of privacy and confidentiality in electronic communications, regulating data processing in this sector.
Directive 2005/29/EC
This directive prohibits unfair commercial practices that harm consumers and amends several previous directives related to business-to-consumer practices.
- ← AI system: The AI system's prohibitions on manipulative practices are complementary to the provisions of Directive 2005/29/EC.
- → Council Directive 84/450/EEC: Directive 2005/29/EC amends Council Directive 84/450/EEC regarding unfair commercial practices.
- → Regulation (EC) No 2006/2004: Directive 2005/29/EC amends Regulation (EC) No 2006/2004 concerning consumer protection.
Directive 2006/42/EC
A directive establishing essential health and safety requirements for machinery within the EU.
Directive 2008/48/EC
A directive concerning credit agreements for consumers, which repeals Council Directive 87/102/EEC.
Directive 2009/138/EC
A directive from the European Parliament and Council concerning the business of insurance and reinsurance in the EU, known as Solvency II.
Directive 2009/22/EC
An earlier directive that was repealed by Directive (EU) 2020/1828 regarding collective consumer interests.
Directive 2009/48/EC
A directive concerning the safety of toys, adopted by the European Parliament and Council.
Directive 2013/32/EU
A directive from the European Parliament and Council that establishes common procedures for granting and withdrawing international protection in the EU.
Directive 2013/36/EU
A directive from the European Parliament and Council that establishes rules for the prudential supervision of credit institutions and investment firms in the EU, amending previous directives.
- → Council Regulation (EU) No 1024/2013: Directive 2013/36/EU acts in accordance with the provisions established by Council Regulation (EU) No 1024/2013.
- ← Regulation (EU) No 1024/2013: The regulation aims to integrate procedural obligations related to risk management into the existing obligations under Directive 2013/36/EU.
- → high-risk AI systems: The directive includes provisions that apply to the monitoring obligations of deployers of high-risk AI systems.
- → Directive 2002/87/EC: Directive 2013/36/EU amends Directive 2002/87/EC.
- → Directives 2006/48/EC and 2006/49/EC: Directive 2013/36/EU repeals Directives 2006/48/EC and 2006/49/EC.
- → Regulation: The Regulation includes provisions that amend or relate to the Directive concerning financial institutions.
Directive 2013/53/EU
Directive of the European Parliament and of the Council on recreational craft and personal watercraft, established on 20 November 2013.
- → 2013-11-20: The directive was established on this date.
Directive 2014/17/EU
A directive of the European Parliament and Council on credit agreements for consumers relating to residential immovable property, amending Directives 2008/48/EC and 2013/36/EU and Regulation (EU) No 1093/2010.
Directive 2014/31/EU
A directive by the European Parliament and Council on the harmonisation of laws regarding non-automatic weighing instruments.
- → market: This directive affects the market by regulating the availability of non-automatic weighing instruments.
Directive 2014/32/EU
A directive by the European Parliament and Council on the harmonisation of laws regarding measuring instruments.
- → market: This directive affects the market by regulating the availability of measuring instruments.
Directive 2014/33/EU
Directive of the European Parliament and of the Council on the harmonisation of laws relating to lifts and safety components for lifts, established on 26 February 2014.
- → 2014-02-26: The directive was established on this date.
Directive 2014/34/EU
Directive of the European Parliament and of the Council on the harmonisation of laws relating to equipment and protective systems for potentially explosive atmospheres, established on 26 February 2014.
- → 2014-02-26: The directive was established on this date.
Directive 2014/53/EU
Directive of the European Parliament and of the Council on the harmonisation of laws relating to the market availability of radio equipment, established on 16 April 2014.
- → 2014-04-16: The directive was established on this date.
Directive 2014/68/EU
Directive of the European Parliament and of the Council on the harmonisation of laws relating to the market availability of pressure equipment, established on 15 May 2014.
- → 2014-05-15: The directive was established on this date.
Directive 2014/90/EU
A directive concerning the safety of maritime equipment, which is being amended to include provisions related to artificial intelligence systems.
Directive 98/79/EC
A directive that was repealed by Regulation (EU) 2017/746, concerning in vitro diagnostic medical devices.
Directives 2014/31/EU
A directive from the European Parliament and Council aimed at ensuring the accuracy of measurements in commercial transactions.
Directives 2014/32/EU
Another directive from the European Parliament and Council focused on legal metrology to promote transparency and fairness in commercial transactions.
Directives 2014/90/EU, 2016/797, 2020/1828
A set of directives that are amended by Regulation (EU) 2024/1689.
- ← Regulation (EU) 2024/1689: Regulation (EU) 2024/1689 amends several directives including 2014/90/EU, 2016/797, and 2020/1828.
Directives 96/9/EC and 2001/29/EC
Previous directives that were amended by Directive (EU) 2019/790, concerning copyright and related rights.
discrimination
The unjust or prejudicial treatment of different categories of people, often highlighted in the context of AI systems and their outputs.
- ← high-risk AI system: The outputs of high-risk AI systems can perpetuate discrimination, impacting market fairness.
discriminatory outcomes
Negative results that may arise from the use of AI systems, leading to unfair treatment of individuals or groups.
distributor
A natural or legal person in the supply chain, other than the provider or the importer, that makes an AI system available on the Union market.
- → AI system: The distributor makes AI systems available on the Union market.
downstream provider
A downstream provider is responsible for fulfilling obligations related to AI systems, integrating AI models regardless of their source.
- → AI systems: Downstream providers must comply with obligations related to AI systems.
- → general-purpose AI system: Downstream providers act in accordance with the regulations governing general-purpose AI systems.
- ← Article 4: Article 4 affects the market by setting standards for AI literacy among downstream providers.
drivers
Individuals whose fatigue states may be monitored to prevent accidents, not included in the emotion recognition system.
Education and vocational training
AI systems intended for use in educational settings to determine access, evaluate learning outcomes, and assess educational levels.
- → High-risk AI systems: AI systems in education and vocational training are recognized as high-risk.
effective remedy
The right to seek a legal remedy or correction when one's rights are violated, which could be affected by AI system decisions.
- ← AI systems: The decisions made by AI systems can affect the right to an effective remedy.
ELI
The European Legislation Identifier, a unique identifier providing access to legal documents, including the Regulation.
- ← Regulation: The Regulation includes a link to the electronic legal information system for further reference.
- ← OJ L: The date of publication in the Official Journal of the European Union is linked to the European Legislation Identifier.
ELI: http://data.europa.eu/eli/reg/2024/1689/oj
The electronic legal information reference for Regulation 2024/1689, providing access to the official text.
ELI: http://data.europa.eu/eli/reg/2024/1689/oj
The European Legislation Identifier link to the regulation document.
Emergency response AI systems
AI systems used to evaluate and classify emergency calls and dispatch emergency services, classified as high-risk due to their critical decision-making role.
- → Union law: Emergency response AI systems are classified under Union law as high-risk due to their critical functions.
emotion recognition system
An AI system that identifies or infers the emotions or intentions of individuals based on their biometric data.
- ← Regulation on the ‘real-time’ use of AI systems: The regulation establishes rules governing the use of emotion recognition systems.
- → biometric data: The emotion recognition system processes biometric data to identify emotions.
- → professional pilots: The emotion recognition system does not include monitoring fatigue states of professional pilots.
- → drivers: The emotion recognition system does not include monitoring fatigue states of drivers.
- → personal data: Deployers must inform individuals about the operation of the emotion recognition system and how personal data is processed.
energy consumption
The known or estimated energy usage of an AI model during its operation.
ENISA
The European Union Agency for Cybersecurity, responsible for improving the overall cybersecurity posture of the EU and involved in regulatory implementation.
environmental sustainability
Environmental sustainability is a key consideration in assessing the impact of AI systems, focusing on energy-efficient programming and design.
- ← codes of conduct: Codes of conduct may include parameters related to environmental sustainability.
- ← Commission: The Commission aims to improve the environmental sustainability of AI systems through evaluations.
ethical principles
Guidelines for the development of AI systems that promote diversity, non-discrimination, and fairness.
- ← AI system: AI systems should be developed in alignment with ethical principles to ensure fairness and non-discrimination.
- → codes of conduct: The ethical principles should inform the drafting of codes of conduct for AI systems.
- ← stakeholders: Stakeholders are encouraged to take ethical principles into account when developing AI practices.
Ethics Guidelines for Trustworthy AI
Guidelines established by the Union to promote ethical and trustworthy practices in the development and deployment of AI systems.
- ← providers of AI systems: Providers of AI systems are encouraged to apply additional requirements related to the Ethics Guidelines for Trustworthy AI.
ethnic or religious minorities
Groups that may be more susceptible to exploitation by AI systems due to their social status.
ethnic or religious minorities
Groups that may be more susceptible to exploitation by AI systems, as highlighted in the text.
ETSI
The European Telecommunications Standards Institute, a permanent member of the advisory forum that may contribute to the Regulation's implementation.
EU database
A publicly accessible database managed by the European Commission for registering high-risk AI systems and their providers, ensuring compliance with relevant regulations.
- ← AI system: AI systems must be registered in the EU database established under Regulation (EU) 2016/679.
- ← Commission: The Commission is responsible for establishing and managing the EU database for high-risk AI systems.
- ← public authorities: Public authorities deploying high-risk AI systems must register in the EU database.
- → Directive (EU) 2019/882: The EU database must comply with the requirements set forth in Directive (EU) 2019/882.
- → competent authorities: The EU database is used by competent authorities to register testing activities.
- ← real-time remote biometric identification system: The regulation lays down rules for the registration of the biometric identification system in the EU database.
- ← provider: Providers must register themselves and their high-risk AI systems in the EU database.
- ← Article 71: Article 71 refers to the EU database where high-risk AI systems must be registered.
- ← Annex III: Annex III includes safeguards for the registration of high-risk AI systems in the EU database.
- ← Annex VIII: Annex VIII requires specific documentation for the registration of high-risk AI systems in the EU database.
- ← Commission: The Commission has an opinion on the access to the restricted sections of the EU database.
- ← national authorities: National authorities have an opinion on the access to the restricted sections of the EU database.
- → Article 49(4): The EU database includes provisions outlined in Article 49(4) for testing registration.
- → Article 49(5): The EU database includes provisions outlined in Article 49(5) for testing registration.
- ← providers: Providers enter data into the EU database as required by the regulation.
- ← deployer: Deployers enter data into the EU database on behalf of public authorities.
- ← Article 49: Article 49 outlines the requirements for data entry into the EU database.
- → personal data: The EU database contains personal data necessary for compliance with regulations.
- ← Commission: The Commission controls the EU database and ensures it meets accessibility requirements.
- ← AI system: The AI system's information is submitted to the EU database by its provider.
EU database
A dedicated database for registering AI system testing activities, managed by competent authorities.
- ← AI system: AI systems must be registered in the EU database established under Regulation (EU) 2016/679.
- ← Commission: The Commission is responsible for establishing and managing the EU database for high-risk AI systems.
- ← public authorities: Public authorities deploying high-risk AI systems must register in the EU database.
- → Directive (EU) 2019/882: The EU database must comply with the requirements set forth in Directive (EU) 2019/882.
- → competent authorities: The EU database is used by competent authorities to register testing activities.
- ← real-time remote biometric identification system: The regulation lays down rules for the registration of the biometric identification system in the EU database.
- ← provider: Providers must register themselves and their high-risk AI systems in the EU database.
- ← Article 71: Article 71 refers to the EU database where high-risk AI systems must be registered.
- ← Annex III: Annex III includes safeguards for the registration of high-risk AI systems in the EU database.
- ← Annex VIII: Annex VIII requires specific documentation for the registration of high-risk AI systems in the EU database.
- ← Commission: The Commission has an opinion on the access to the restricted sections of the EU database.
- ← national authorities: National authorities have an opinion on the access to the restricted sections of the EU database.
- → Article 49(4): The EU database includes provisions outlined in Article 49(4) for testing registration.
- → Article 49(5): The EU database includes provisions outlined in Article 49(5) for testing registration.
- ← providers: Providers enter data into the EU database as required by the regulation.
- ← deployer: Deployers enter data into the EU database on behalf of public authorities.
- ← Article 49: Article 49 outlines the requirements for data entry into the EU database.
- → personal data: The EU database contains personal data necessary for compliance with regulations.
- ← Commission: The Commission controls the EU database and ensures it meets accessibility requirements.
- ← AI system: The AI system's information is submitted to the EU database by its provider.
EU database for high-risk AI systems
A database established to maintain information on high-risk AI systems as outlined in the regulation.
- ← Commission: The Commission proposes to set up and maintain the EU database for high-risk AI systems.
- → Annex III: The EU database contains information concerning high-risk AI systems as referred to in Annex III.
- → Annex VIII: The EU database requires data listed in Annex VIII to be entered by the provider or authorized representative.
EUR 1 500 000
The maximum administrative fine for non-compliance with the prohibition of certain AI practices as stated in Article 5.
- ← Article 5: Article 5 lays down the rules for the maximum fine for non-compliance with prohibited AI practices.
EUR 35 000 000
The maximum administrative fine for non-compliance with the prohibition of certain AI practices.
- ← Article 99: Article 99 specifies a maximum fine of EUR 35 000 000 for non-compliance.
EUR 750 000
The maximum administrative fine for non-compliance with any requirements or obligations under the regulation, excluding those in Article 5.
- ← regulation: The regulation specifies the maximum fine of EUR 750 000 for non-compliance with other requirements.
EuroHPC Joint Undertaking
A European initiative aimed at developing a world-class supercomputing infrastructure.
- ← AI Office: The AI Office will make use of existing resources and expertise, including synergies with the EuroHPC Joint Undertaking.
European Artificial Intelligence Board
A consultative body established to oversee and guide the implementation of AI regulations and best practices within the European Union.
- → Commission: The Board supports the Commission in promoting AI literacy tools.
- → Article 96: The Board acts in accordance with Article 96 to provide guidelines for the implementation of AI regulations.
- ← Regulation 2024/1689: The regulation proposes the establishment of the European Artificial Intelligence Board.
- ← Article 65: Article 65 details the establishment and structure of the European Artificial Intelligence Board.
- → Member States: The Board is composed of one representative per Member State.
- ← European Data Protection Supervisor: The European Data Protection Supervisor participates as an observer in the Board's meetings.
- → Article 66: The Board's tasks are referred to in Article 66 of the regulation.
- ← Member States: Member States designate representatives to the Board for a period of three years.
- → Article 65: Article 65 outlines the establishment and structure of the European Artificial Intelligence Board.
European Artificial Intelligence Office
An office responsible for developing templates and guidelines to facilitate compliance for AI system deployers.
- → general-purpose AI models: The office provides specific rules for general-purpose AI models to ensure compliance and safety.
European Central Bank
The central bank for the euro, responsible for administering monetary policy within the Eurozone and overseeing financial system stability.
- ← National authorities: National authorities report information to the European Central Bank during market surveillance activities.
- ← Regulation (EU) No 1024/2013: The regulation requires market surveillance authorities to report information regarding market surveillance activities to the European Central Bank.
- ← Council Regulation (EU) No 1024/2013: Council Regulation (EU) No 1024/2013 confers specific tasks on the European Central Bank.
- → Regulation (EU) 2019/1020: The European Central Bank has specific tasks conferred by Regulation (EU) 2019/1020 regarding the supervision of credit institutions.
European Commission
The European Commission is the executive branch of the EU responsible for proposing legislation, implementing decisions, and upholding EU treaties.
European Data Protection Board
An independent European body that ensures consistent application of data protection rules across the EU.
- ← 2024/1689: The regulation proposes to consult the European Data Protection Board regarding specific rules.
- ← Article 16 TFEU: The regulation on Article 16 TFEU suggests consulting the European Data Protection Board.
- → 18 June 2021: The European Data Protection Board delivered its joint opinion on 18 June 2021.
European Data Protection Supervisor
An independent supervisory authority ensuring compliance with data protection laws in the EU, overseeing institutions and potentially establishing AI regulatory sandboxes.
- → Union institutions, agencies and bodies: The European Data Protection Supervisor acts as a market surveillance authority for Union institutions.
- ← Member States: Member States must report compliance and enforcement actions to the European Data Protection Supervisor.
- → Member States: The European Data Protection Supervisor provides opinions on the implementation of the regulation by Member States.
- → Regulation: The European Data Protection Supervisor has the power to impose fines under this Regulation.
- ← Regulation (EU) 2018/1725: The European Data Protection Supervisor was consulted in accordance with Article 42 of Regulation (EU) 2018/1725.
- → AI regulatory sandbox: The European Data Protection Supervisor may establish an AI regulatory sandbox for Union institutions.
- ← AI regulatory sandboxes: AI regulatory sandboxes may involve the European Data Protection Supervisor in their operations to ensure compliance with data protection regulations.
- → European Artificial Intelligence Board: The European Data Protection Supervisor participates as an observer in the Board's meetings.
- → Market surveillance authorities: Acts as the market surveillance authority for Union institutions, bodies, offices, or agencies.
- → Article 100: The European Data Protection Supervisor acts in accordance with Article 100 when imposing administrative fines.
- → AI system: The European Data Protection Supervisor oversees compliance related to AI systems.
- → Union institution, body, office or agency: The European Data Protection Supervisor notifies the Union institution of administrative fines imposed.
European Digital Innovation Hubs
Entities that support digital transformation and innovation in Europe by providing access to technology, expertise, and high-quality data sets.
- → data sets: These hubs provide access to high-quality data sets necessary for the development of AI systems.
- ← AI regulatory sandbox: The AI regulatory sandbox may involve European Digital Innovation Hubs to support innovation.
- → this Regulation: These hubs facilitate compliance and implementation of the Regulation for providers.
- → Regulation: The hubs provide support for the implementation of the Regulation.
- ← AI regulatory sandbox: The AI regulatory sandbox includes safeguards by directing providers to European Digital Innovation Hubs for support.
European Economic and Social Committee
An advisory body of the European Union that will also receive reports regarding the Regulation.
- ← Commission: The Commission will inform the European Economic and Social Committee about the assessment.
European harmonised standard
A standard that, once published and assessed, grants providers the presumption of conformity with obligations.
- → obligations: Compliance with a European harmonised standard provides a presumption of conformity with obligations.
European harmonised standards
Standards that, when complied with, grant providers a presumption of conformity regarding their obligations.
European health data space
A common data space that facilitates access to health data for training AI algorithms in a privacy-preserving manner.
- → AI system: The health data space allows for the training of AI algorithms using health data.
European Parliament
The European Parliament is the directly elected legislative body of the EU, sharing power with the Council and involved in creating and adopting EU legislation.
- ← Directive (EU) 2019/882: The directive is proposed by the European Parliament.
- ← Directive (EU) 2019/790: The directive was proposed by the European Parliament.
- ← Commission: The Commission submits evaluations, assessments, and reports related to the Regulation to the European Parliament.
- → Commission: The European Parliament receives notifications from the Commission regarding delegated acts.
- ← Commission: The Commission notifies the European Parliament of adopted delegated acts.
- ← Regulation (EU) 2024/1689: Regulation (EU) 2024/1689 is proposed by the European Parliament.
- ← Regulation (EU) 2024/1689: Regulation (EU) 2024/1689 is enacted in accordance with the legislative processes of the European Parliament.
European Parliament and Council
The legislative bodies of the European Union responsible for enacting directives and regulations.
- → Directives 2014/31/EU: The European Parliament and Council issued Directive 2014/31/EU to ensure measurement accuracy.
- → Directives 2014/32/EU: The European Parliament and Council issued Directive 2014/32/EU to promote transparency in commercial transactions.
- ← Directive (EU) 2020/1828: The Directive was proposed by the European Parliament and Council.
European Parliament and Council Regulation
A regulation that sets horizontal cybersecurity requirements for products with digital elements, which high-risk AI systems must comply with.
- ← high-risk AI systems: High-risk AI systems can demonstrate compliance with cybersecurity requirements by fulfilling the essential requirements of the regulation.
- → EU declaration of conformity: The regulation requires an EU declaration of conformity to demonstrate compliance with cybersecurity requirements.
European Parliament and of the Council
The legislative body of the European Union, responsible for enacting legislation and representing EU citizens.
- ← Directive (EU) 2016/797: The directive is enacted by the European Parliament and Council, transmitting legislative authority.
European standardisation organisations
These organisations develop and maintain standards across various sectors in Europe, including AI, ensuring they meet stakeholder needs.
- ← Regulation (EU) No 1025/2012: The regulation requires documentation from European standardisation organisations to ensure compliance.
- → Regulation (EU) No 1025/2012: European standardisation organisations are required to act in accordance with the provisions of Regulation (EU) No 1025/2012.
- ← Commission: The Commission transmits standardisation requests to European standardisation organisations to ensure compliance with regulations.
- ← Regulation (EU) No 1025/2012: Regulation (EU) No 1025/2012 proposes that the Commission requests European standardisation organisations to draft harmonised standards.
- → Official Journal of the European Union: European standardisation organisations transmit references to harmonised standards to the Official Journal of the European Union.
European Union
The European Union is a political and economic union of member states primarily located in Europe, with its own institutions and laws responsible for establishing regulations and directives.
- ← Regulation 2024/1689: The regulation requires compliance from the European Union institutions and bodies.
- → Article 15: The European Union establishes cybersecurity requirements in Article 15.
Europol
The European Union Agency for Law Enforcement Cooperation, assisting member states in combating serious international crime and terrorism.
- → third country: Europol may cooperate with third countries under established agreements for law enforcement purposes.
- ← Regulation 2024/1689: Europol must ensure its operations comply with the stipulations of the regulation.
evaluation strategies
Strategies for evaluating AI models, including criteria, metrics, and methodologies.
exit report
A document detailing the activities carried out in the AI regulatory sandbox, including results and learning outcomes, provided by the competent authority.
- ← AI regulatory sandbox: The activities carried out in the AI regulatory sandbox are documented in an exit report.
- ← Article 78: Article 78 outlines confidentiality provisions regarding the access to exit reports.
extreme poverty
A social condition that makes individuals more vulnerable to exploitation, mentioned in the context of AI systems.
- ← AI systems: AI systems can exploit individuals living in extreme poverty.
facial recognition databases
Databases storing facial images for identification purposes, often created through the scraping of images from various sources, raising significant privacy concerns.
- ← AI systems: The use of AI systems to create or expand facial recognition databases through untargeted scraping should be prohibited.
- → fundamental rights: The use of facial recognition databases can lead to violations of fundamental rights, including privacy.
- → AI system: The regulation proposes restrictions on the use of AI systems that create or expand facial recognition databases.
fair trial
The right to a legal process that is fair and impartial, which may be compromised by the use of AI systems in legal contexts.
- ← AI systems: The use of AI systems may compromise the right to a fair trial.
feedback loops
Processes where the output of a system is fed back into the system as input, which can lead to biased outcomes if not managed properly.
- ← High-risk AI systems: High-risk AI systems must manage feedback loops to prevent biased outputs from affecting future operations.
filters categorising facial or body features
Technological features used in online marketplaces and social networks to categorize users based on their physical attributes.
- → online marketplaces: Filters used in online marketplaces act in accordance with the principal service of selling products.
- → online social network services: Filters used in online social network services act in accordance with the principal service of sharing content.
fine-tuning
A process that adjusts the parameters of a pre-trained AI model to improve its performance on specific tasks.
- ← general-purpose AI model: Fine-tuning is a critical process for adjusting the performance of general-purpose AI models after initial training.
fingerprints
Unique identifiers used to trace the origin of content generated by AI systems.
- ← AI systems: AI systems may use fingerprints to trace the origin of generated content.
floating point operations
A measure of the cumulative amount of computation used for training general-purpose AI models, relevant for assessing their capabilities.
- ← general-purpose AI model: The capabilities of general-purpose AI models are evaluated based on the cumulative floating point operations used during their training.
Free and open-source AI components
Software and data, including models, that can be shared and modified freely under specific licensing conditions.
- → Regulation: The Regulation includes safeguards for free and open-source AI components to ensure they are not monetized improperly.
- ← personal data: The use of personal data in relation to free and open-source AI components must be documented and limited.
free and open-source licence
A licensing model that allows tools, services, and components to be used freely without compliance mandates.
- → AI system: Tools and services under this licence are not mandated to comply with certain regulatory requirements.
fundamental rights
Fundamental rights and freedoms that must be protected in the context of AI deployment, including the right to privacy.
- ← AI systems: AI systems are designed to enhance the protection of fundamental rights.
- ← facial recognition databases: The use of facial recognition databases can lead to violations of fundamental rights, including privacy.
- ← AI systems: AI systems can adversely impact fundamental rights, particularly in data protection and privacy, which is critical for their classification as high risk.
- ← Charter: The Charter outlines the fundamental rights that must be protected in the context of AI systems.
- → AI systems: The accuracy and transparency of AI systems aim to improve the respect for fundamental rights of affected persons.
- ← national competent authorities: National competent authorities supervise the protection of fundamental rights in the context of AI systems.
- ← AI system: The deployment of AI systems can impact fundamental rights, leading to potential harm or adverse effects.
- ← AI regulatory sandboxes: AI regulatory sandboxes include safeguards to mitigate risks to fundamental rights and society.
- ← AI regulatory sandbox: The AI regulatory sandbox aims to improve the protection of fundamental rights during AI system development.
fundamental rights
Basic human rights protected by the Charter, including privacy and non-discrimination, which are critical in the context of AI system deployment.
- ← AI systems: AI systems are designed to enhance the protection of fundamental rights.
- ← facial recognition databases: The use of facial recognition databases can lead to violations of fundamental rights, including privacy.
- ← AI systems: AI systems can adversely impact fundamental rights, particularly in data protection and privacy, which is critical for their classification as high risk.
- ← Charter: The Charter outlines the fundamental rights that must be protected in the context of AI systems.
- → AI systems: The accuracy and transparency of AI systems aim to improve the respect for fundamental rights of affected persons.
- ← national competent authorities: National competent authorities supervise the protection of fundamental rights in the context of AI systems.
- ← AI system: The deployment of AI systems can impact fundamental rights, leading to potential harm or adverse effects.
- ← AI regulatory sandboxes: AI regulatory sandboxes include safeguards to mitigate risks to fundamental rights and society.
- ← AI regulatory sandbox: The AI regulatory sandbox aims to improve the protection of fundamental rights during AI system development.
fundamental rights
Basic human rights that must be protected during the development and testing of AI systems.
- ← AI systems: AI systems are designed to enhance the protection of fundamental rights.
- ← facial recognition databases: The use of facial recognition databases can lead to violations of fundamental rights, including privacy.
- ← AI systems: AI systems can adversely impact fundamental rights, particularly in data protection and privacy, which is critical for their classification as high risk.
- ← Charter: The Charter outlines the fundamental rights that must be protected in the context of AI systems.
- → AI systems: The accuracy and transparency of AI systems aim to improve the respect for fundamental rights of affected persons.
- ← national competent authorities: National competent authorities supervise the protection of fundamental rights in the context of AI systems.
- ← AI system: The deployment of AI systems can impact fundamental rights, leading to potential harm or adverse effects.
- ← AI regulatory sandboxes: AI regulatory sandboxes include safeguards to mitigate risks to fundamental rights and society.
- ← AI regulatory sandbox: The AI regulatory sandbox aims to improve the protection of fundamental rights during AI system development.
Fundamental Rights Agency
An agency ensuring the respect of fundamental rights within the context of the Regulation and participating in the advisory forum.
- ← advisory forum: The Fundamental Rights Agency is a permanent member of the advisory forum.
fundamental rights concerns
Issues related to the protection of fundamental rights that must be addressed in the context of standardisation.
- ← harmonised standards: Harmonised standards must adequately address fundamental rights concerns to ensure market compliance.
fundamental rights impact assessment
This assessment evaluates the impact of biometric identification systems on fundamental rights and identifies risks to individuals affected by high-risk AI systems.
Fundamental rights impact assessment
An assessment that deployers must perform to evaluate the impact of high-risk AI systems on fundamental rights.
- ← deployers: Deployers of high-risk AI systems must perform a fundamental rights impact assessment before deployment.
fundamental rights impact assessments
Assessments conducted to evaluate the impact of AI systems on fundamental rights.
- ← deployer: The deployer may rely on previously conducted fundamental rights impact assessments.
general-purpose AI model
A type of AI model designed for a wide range of applications, subject to regulatory evaluations and potential systemic risks.
- → general-purpose AI system: The general-purpose AI model is integrated into the general-purpose AI system, enabling it to serve various purposes.
- → AI Office: Providers of general-purpose AI models must prepare technical documentation and notify the AI Office about the model's classification and systemic risks.
- → national competent authorities: The provider must also make technical documentation available to national competent authorities upon request.
- → systemic risks: General-purpose AI models are evaluated against parameters related to their associated systemic risks due to their high-impact capabilities.
- → floating point operations: The capabilities of general-purpose AI models are evaluated based on the cumulative floating point operations used during their training.
- → pre-training: Pre-training is a necessary step in the development of general-purpose AI models to enhance their capabilities.
- → synthetic data generation: Synthetic data generation is one of the methods used to improve the capabilities of general-purpose AI models.
- → fine-tuning: Fine-tuning is a critical process for adjusting the performance of general-purpose AI models after initial training.
- → threshold of floating point operations: The general-purpose AI model is assessed based on whether it meets the threshold of floating point operations.
- ← Commission: The Commission may propose to designate a general-purpose AI model as having systemic risks based on assessments.
- ← criteria for designation: The criteria for designation includes safeguards for assessing systemic risks of general-purpose AI models.
- ← training data set: The training data set is a parameter that influences the assessment of the general-purpose AI model's risks.
- ← AI Office: The AI Office acts in accordance with the regulations concerning the classification of AI models with systemic risks.
- ← Regulation 2024/1689: The regulation lays down rules for the classification and management of general-purpose AI models that may present systemic risks.
- → Union market: General-purpose AI models can be placed on the Union market.
- → high-impact capabilities: Describes the capabilities that general-purpose AI models can possess.
- ← Article 51: Article 51 establishes rules for the classification and assessment of general-purpose AI models with systemic risk.
- → high impact capabilities: General-purpose AI models are evaluated based on their high impact capabilities.
- → 1025: The threshold of 1025 floating point operations is used to determine if a general-purpose AI model has high impact capabilities.
- ← Commission: The Commission designates a general-purpose AI model as presenting systemic risks based on specific criteria.
- → Annex XIII: The designation of a general-purpose AI model as presenting systemic risks is based on criteria set out in Annex XIII.
- → AI Office: Providers of general-purpose AI models must transmit documentation to the AI Office.
- → Article 53: The general-purpose AI model must comply with obligations outlined in Article 53.
- → Article 55: The general-purpose AI model may also need to comply with additional obligations in Article 55.
- → Regulation 2024/1689: The general-purpose AI model must comply with the obligations set forth in Regulation 2024/1689.
- ← Commission: The Commission may request documentation from the provider of the general-purpose AI model.
- ← scientific panel: The scientific panel may issue a request for information regarding the general-purpose AI model.
- ← Article 101: Article 101 includes provisions for fines related to misleading information about the general-purpose AI model.
- ← AI Office: The AI Office requires documentation and access to the general-purpose AI model for evaluations.
- ← Article 101: Article 101 lays down rules regarding fines for providing incorrect information related to the general-purpose AI model.
- ← AI Office: The AI Office may initiate a structured dialogue with the provider of the general-purpose AI model.
- → Article 92: The evaluation of the general-purpose AI model may give rise to concerns about systemic risks at the Union level as outlined in Article 92.
- ← AI Office: The AI Office may initiate a structured dialogue with the provider of the general-purpose AI model.
- → parameters: The general-purpose AI model includes specific parameters that define its architecture.
- → modality: The general-purpose AI model can handle various modalities for input and output.
- → data: The AI model utilizes a specific data set for training, testing, and validation.
- → computational resources: The AI model requires computational resources for its training process.
- → energy consumption: The AI model's energy consumption is a parameter that is known or estimated.
- ← technical documentation: Technical documentation is required for the integration of the general-purpose AI model into AI systems.
- → date of release: The general-purpose AI model has a specific date of release.
- → data used for training: The general-purpose AI model is trained using specific datasets.
- → acceptable use policies: The general-purpose AI model includes acceptable use policies as safeguards.
general-purpose AI model
A type of AI model designed for a wide range of applications, which can be placed on the market.
- → general-purpose AI system: The general-purpose AI model is integrated into the general-purpose AI system, enabling it to serve various purposes.
- → AI Office: Providers of general-purpose AI models must prepare technical documentation and notify the AI Office about the model's classification and systemic risks.
- → national competent authorities: The provider must also make technical documentation available to national competent authorities upon request.
- → systemic risks: General-purpose AI models are evaluated against parameters related to their associated systemic risks due to their high-impact capabilities.
- → floating point operations: The capabilities of general-purpose AI models are evaluated based on the cumulative floating point operations used during their training.
- → pre-training: Pre-training is a necessary step in the development of general-purpose AI models to enhance their capabilities.
- → synthetic data generation: Synthetic data generation is one of the methods used to improve the capabilities of general-purpose AI models.
- → fine-tuning: Fine-tuning is a critical process for adjusting the performance of general-purpose AI models after initial training.
- → threshold of floating point operations: The general-purpose AI model is assessed based on whether it meets the threshold of floating point operations.
- ← Commission: The Commission may propose to designate a general-purpose AI model as having systemic risks based on assessments.
- ← criteria for designation: The criteria for designation includes safeguards for assessing systemic risks of general-purpose AI models.
- ← training data set: The training data set is a parameter that influences the assessment of the general-purpose AI model's risks.
- ← AI Office: The AI Office acts in accordance with the regulations concerning the classification of AI models with systemic risks.
- ← Regulation 2024/1689: The regulation lays down rules for the classification and management of general-purpose AI models that may present systemic risks.
- → Union market: General-purpose AI models can be placed on the Union market.
- → high-impact capabilities: Describes the capabilities that general-purpose AI models can possess.
- ← Article 51: Article 51 establishes rules for the classification and assessment of general-purpose AI models with systemic risk.
- → high impact capabilities: General-purpose AI models are evaluated based on their high impact capabilities.
- → 1025: The threshold of 1025 floating point operations is used to determine if a general-purpose AI model has high impact capabilities.
- ← Commission: The Commission designates a general-purpose AI model as presenting systemic risks based on specific criteria.
- → Annex XIII: The designation of a general-purpose AI model as presenting systemic risks is based on criteria set out in Annex XIII.
- → AI Office: Providers of general-purpose AI models must transmit documentation to the AI Office.
- → Article 53: The general-purpose AI model must comply with obligations outlined in Article 53.
- → Article 55: The general-purpose AI model may also need to comply with additional obligations in Article 55.
- → Regulation 2024/1689: The general-purpose AI model must comply with the obligations set forth in Regulation 2024/1689.
- ← Commission: The Commission may request documentation from the provider of the general-purpose AI model.
- ← scientific panel: The scientific panel may issue a request for information regarding the general-purpose AI model.
- ← Article 101: Article 101 includes provisions for fines related to misleading information about the general-purpose AI model.
- ← AI Office: The AI Office requires documentation and access to the general-purpose AI model for evaluations.
- ← Article 101: Article 101 lays down rules regarding fines for providing incorrect information related to the general-purpose AI model.
- ← AI Office: The AI Office may initiate a structured dialogue with the provider of the general-purpose AI model.
- → Article 92: The evaluation of the general-purpose AI model may give rise to concerns about systemic risks at the Union level as outlined in Article 92.
- ← AI Office: The AI Office may initiate a structured dialogue with the provider of the general-purpose AI model.
- → parameters: The general-purpose AI model includes specific parameters that define its architecture.
- → modality: The general-purpose AI model can handle various modalities for input and output.
- → data: The AI model utilizes a specific data set for training, testing, and validation.
- → computational resources: The AI model requires computational resources for its training process.
- → energy consumption: The AI model's energy consumption is a parameter that is known or estimated.
- ← technical documentation: Technical documentation is required for the integration of the general-purpose AI model into AI systems.
- → date of release: The general-purpose AI model has a specific date of release.
- → data used for training: The general-purpose AI model is trained using specific datasets.
- → acceptable use policies: The general-purpose AI model includes acceptable use policies as safeguards.
general-purpose AI models
AI models capable of performing a wide range of tasks, typically trained on large datasets and designed for various applications.
- ← European Artificial Intelligence Office: The office provides specific rules for general-purpose AI models to ensure compliance and safety.
- → AI systems: General-purpose AI models are integrated into AI systems along with additional components.
- → data: General-purpose AI models are trained on large amounts of data, necessitating proper documentation.
- → self-supervised learning: General-purpose AI models can be trained using self-supervised learning methods.
- → unsupervised learning: General-purpose AI models can also utilize unsupervised learning techniques for training.
- → reinforcement learning: Reinforcement learning is another method employed in training general-purpose AI models.
- → Regulation: The Regulation establishes obligations for the providers of general-purpose AI models once they are placed on the market.
- → internal processes: General-purpose AI models do not apply obligations when used solely for internal processes that do not affect third parties.
- → Directive (EU) 2019/790: General-purpose AI models must comply with transparency-related requirements and obligations set forth in Directive (EU) 2019/790 unless they present a systemic risk.
- → personal data: General-purpose AI models may utilize personal data for various purposes, including training and fine-tuning.
- → open-source license: General-purpose AI models released under an open-source license must have their parameters publicly available.
- → text and data mining: General-purpose AI models may utilize text and data mining techniques.
- → Union market: General-purpose AI models must comply with copyright regulations to be placed on the Union market.
- ← rightsholders: Rightsholders require that providers of general-purpose AI models obtain authorization for text and data mining of their works.
- → data collections: General-purpose AI models utilize various data collections for training, which must be disclosed to ensure transparency.
- ← AI Office: The AI Office monitors compliance and possible infringements related to providers of general-purpose AI models.
- → Union copyright law: General-purpose AI models must comply with Union copyright law regarding the use of training data.
- ← technical documentation: Providers of general-purpose AI models are required to complement technical documentation with information on modifications.
- ← training data sources: Training data sources are a type of data set that must be disclosed by providers of general-purpose AI models.
- → Regulation: General-purpose AI models must comply with the documentation requirements set by the Regulation.
- → model evaluations: Providers must conduct model evaluations prior to market placement.
- → risk-management policies: General-purpose AI models with systemic risks must implement risk-management policies.
- → Commission: Providers of general-purpose AI models must report incidents to the Commission.
- → national competent authorities: Providers must transmit relevant information about incidents to national competent authorities.
- ← cybersecurity protection: Cybersecurity protection includes safeguards for general-purpose AI models against systemic risks.
- ← codes of practice: Codes of practice establish guidelines for compliance for providers of general-purpose AI models.
- ← AI systems: AI systems can include general-purpose AI models for content generation.
- → AI systems: General-purpose AI models serve as the basis for specific AI systems, influencing their design and functionality.
- ← scientific panel: The scientific panel can assess risks associated with general-purpose AI models.
- → common specifications: General-purpose AI models must also comply with the common specifications set out in the regulation.
- → AI Office: Providers must submit technical documentation to the AI Office.
- → Annex XI: Annex XI outlines the minimum information requirements for the technical documentation.
- → Annex XII: Annex XII specifies elements to be included in the documentation for AI systems.
- → Union law: Providers must comply with Union law regarding copyright and related rights.
- ← 12.7.2024: The regulation concerning general-purpose AI models is published on this date.
- → Regulation 2024/1689: General-purpose AI models must cooperate with the Commission and national authorities as per the regulation.
- → European harmonised standards: General-purpose AI models must comply with European harmonised standards to demonstrate conformity.
- ← AI Office: The AI Office may invite providers of general-purpose AI models to participate in the development of codes of practice.
- ← AI Office: The AI Office invites providers of general-purpose AI models to adhere to the codes of practice.
- ← scientific panel: The scientific panel provides advice on the classification and evaluation of general-purpose AI models.
- ← Commission: The Commission lays down rules for the compliance of providers of general-purpose AI models.
- ← Article 101: Article 101 proposes fines for providers of general-purpose AI models for non-compliance.
- → evaluation strategies: General-purpose AI models require detailed evaluation strategies for assessment.
- → internal and/or external adversarial testing: General-purpose AI models include safeguards such as adversarial testing to ensure robustness.
- → system architecture: Documentation of the system architecture is required for general-purpose AI models.
- → energy consumption: Energy consumption is a parameter associated with general-purpose AI models.
- → computational resources: Computational resources are parameters that define the training of general-purpose AI models.
general-purpose AI models
AI models designed for a wide range of applications, subject to compliance obligations and potential systemic risks.
- ← European Artificial Intelligence Office: The office provides specific rules for general-purpose AI models to ensure compliance and safety.
- → AI systems: General-purpose AI models are integrated into AI systems along with additional components.
- → data: General-purpose AI models are trained on large amounts of data, necessitating proper documentation.
- → self-supervised learning: General-purpose AI models can be trained using self-supervised learning methods.
- → unsupervised learning: General-purpose AI models can also utilize unsupervised learning techniques for training.
- → reinforcement learning: Reinforcement learning is another method employed in training general-purpose AI models.
- → Regulation: The Regulation establishes obligations for the providers of general-purpose AI models once they are placed on the market.
- → internal processes: General-purpose AI models do not apply obligations when used solely for internal processes that do not affect third parties.
- → Directive (EU) 2019/790: General-purpose AI models must comply with transparency-related requirements and obligations set forth in Directive (EU) 2019/790 unless they present a systemic risk.
- → personal data: General-purpose AI models may utilize personal data for various purposes, including training and fine-tuning.
- → open-source license: General-purpose AI models released under an open-source license must have their parameters publicly available.
- → text and data mining: General-purpose AI models may utilize text and data mining techniques.
- → Union market: General-purpose AI models must comply with copyright regulations to be placed on the Union market.
- ← rightsholders: Rightsholders require that providers of general-purpose AI models obtain authorization for text and data mining of their works.
- → data collections: General-purpose AI models utilize various data collections for training, which must be disclosed to ensure transparency.
- ← AI Office: The AI Office monitors compliance and possible infringements related to providers of general-purpose AI models.
- → Union copyright law: General-purpose AI models must comply with Union copyright law regarding the use of training data.
- ← technical documentation: Providers of general-purpose AI models are required to complement technical documentation with information on modifications.
- ← training data sources: Training data sources are a type of data set that must be disclosed by providers of general-purpose AI models.
- → Regulation: General-purpose AI models must comply with the documentation requirements set by the Regulation.
- → model evaluations: Providers must conduct model evaluations prior to market placement.
- → risk-management policies: General-purpose AI models with systemic risks must implement risk-management policies.
- → Commission: Providers of general-purpose AI models must report incidents to the Commission.
- → national competent authorities: Providers must transmit relevant information about incidents to national competent authorities.
- ← cybersecurity protection: Cybersecurity protection includes safeguards for general-purpose AI models against systemic risks.
- ← codes of practice: Codes of practice establish guidelines for compliance for providers of general-purpose AI models.
- ← AI systems: AI systems can include general-purpose AI models for content generation.
- → AI systems: General-purpose AI models serve as the basis for specific AI systems, influencing their design and functionality.
- ← scientific panel: The scientific panel can assess risks associated with general-purpose AI models.
- → common specifications: General-purpose AI models must also comply with the common specifications set out in the regulation.
- → AI Office: Providers must submit technical documentation to the AI Office.
- → Annex XI: Annex XI outlines the minimum information requirements for the technical documentation.
- → Annex XII: Annex XII specifies elements to be included in the documentation for AI systems.
- → Union law: Providers must comply with Union law regarding copyright and related rights.
- ← 12.7.2024: The regulation concerning general-purpose AI models is published on this date.
- → Regulation 2024/1689: General-purpose AI models must cooperate with the Commission and national authorities as per the regulation.
- → European harmonised standards: General-purpose AI models must comply with European harmonised standards to demonstrate conformity.
- ← AI Office: The AI Office may invite providers of general-purpose AI models to participate in the development of codes of practice.
- ← AI Office: The AI Office invites providers of general-purpose AI models to adhere to the codes of practice.
- ← scientific panel: The scientific panel provides advice on the classification and evaluation of general-purpose AI models.
- ← Commission: The Commission lays down rules for the compliance of providers of general-purpose AI models.
- ← Article 101: Article 101 proposes fines for providers of general-purpose AI models for non-compliance.
- → evaluation strategies: General-purpose AI models require detailed evaluation strategies for assessment.
- → internal and/or external adversarial testing: General-purpose AI models include safeguards such as adversarial testing to ensure robustness.
- → system architecture: Documentation of the system architecture is required for general-purpose AI models.
- → energy consumption: Energy consumption is a parameter associated with general-purpose AI models.
- → computational resources: Computational resources are parameters that define the training of general-purpose AI models.
general-purpose AI models with systemic risk
AI models that may present systemic risks and require specific obligations from their providers.
- → Article 55: Providers must document and report information about serious incidents related to these AI models.
- → AI Office: Providers must report relevant information to the AI Office.
general-purpose AI system
An AI system that integrates a general-purpose AI model, capable of serving various purposes directly or as part of other systems.
- ← general-purpose AI model: The general-purpose AI model is integrated into the general-purpose AI system, enabling it to serve various purposes.
- ← Article 4: Article 4 requires documentation on AI literacy measures for staff dealing with AI systems.
- ← Article 5: Article 5 proposes regulations on prohibited AI practices that may involve general-purpose AI systems.
- ← downstream provider: Downstream providers act in accordance with the regulations governing general-purpose AI systems.
General-purpose AI systems
AI systems that can be utilized as high-risk systems or components of other high-risk AI systems for various purposes.
- → high-risk AI systems: General-purpose AI systems may be used as high-risk AI systems or as components of other high-risk AI systems.
governance framework
A framework established by the Regulation to coordinate and support its application at national and Union levels.
- ← Regulation: The Regulation establishes a governance framework for its application.
Hardware
The physical devices on which the AI system is intended to run.
- ← AI System: The AI system is designed to run on specific hardware.
harmonised standard
Harmonised standards are developed to ensure compliance with specific obligations for AI providers and are proposed for publication by European standardisation organisations.
harmonised standard
A standard defined in Article 2(1), point (c), of Regulation (EU) No 1025/2012.
harmonised standards
Harmonised standards ensure compliance with EU legislation and reflect the state of the art in technology and practices relevant to high-risk AI systems.
health and safety
Regulations aimed at ensuring the well-being and protection of individuals in various environments, including those affected by AI.
- ← AI systems: AI systems aim to improve health and safety regulations.
health sector
An industry focused on health services and products, where the reliability of AI systems is critical for diagnostics and decision support.
- → AI systems: The health sector necessitates reliable AI systems that must be documented to ensure safety and effectiveness.
high impact capabilities
Capabilities of an AI model that indicate a significant potential impact, evaluated using technical tools and methodologies.
- ← general-purpose AI model: General-purpose AI models are evaluated based on their high impact capabilities.
- ← Annex XIII: Annex XIII includes criteria that safeguard the evaluation of high impact capabilities of AI models.
high-impact capabilities
Capabilities of AI models that match or exceed those of the most advanced general-purpose AI models, posing significant risks.
- ← general-purpose AI model: Describes the capabilities that general-purpose AI models can possess.
- → systemic risk: Indicates that high-impact capabilities can lead to systemic risks in the market.
high-quality data
Data that meets adequate requirements for performance, accuracy, and robustness, essential for training AI systems effectively.
- ← AI systems: AI systems require high-quality data to function effectively and avoid discriminatory outcomes.
high-risk AI system
An AI system classified as high-risk due to its significant potential impact on health, safety, or fundamental rights, requiring compliance with stringent regulatory obligations and oversight.
- → Union harmonised legislation: High-risk AI systems must comply with the requirements set out in Union harmonised legislation.
- ← risk-management system: The risk-management system aims to improve the safety and compliance of high-risk AI systems.
- ← Regulation: The regulation establishes rules for assessing and managing risks associated with high-risk AI systems.
- → data sets: High-risk AI systems require high-quality data sets for effective training and validation.
- → Union law: High-risk AI systems must ensure compliance with Union law to prevent discrimination.
- ← data sets: Data sets are required for the development and testing of high-risk AI systems.
- → discrimination: The outputs of high-risk AI systems can perpetuate discrimination, impacting market fairness.
- → EU declaration of conformity: High-risk AI systems must demonstrate compliance through an EU declaration of conformity before being marketed.
- ← ENISA: ENISA is involved in the cybersecurity policy related to high-risk AI systems.
- → Directive (EU) 2016/2102: The high-risk AI system must comply with the accessibility requirements set forth in Directive (EU) 2016/2102.
- → Directive (EU) 2019/882: The high-risk AI system must comply with the accessibility requirements set forth in Directive (EU) 2019/882.
- ← United Nations Convention on the Rights of Persons with Disabilities: The convention aims to ensure that AI systems are designed to be accessible to persons with disabilities.
- ← quality management system: The quality management system should be integrated into the design of the high-risk AI system.
- ← AI system: AI systems that comply with obligations set out in regulations.
- ← Commission: The Commission proposes voluntary model contractual terms for cooperation along the AI value chain.
- → impact assessment: The deployment of a high-risk AI system necessitates a thorough impact assessment to identify risks and governance measures.
- → market surveillance authority: After conducting the impact assessment, the deployer must notify the relevant market surveillance authority.
- → Regulation (EU) No 1025/2012: The high-risk AI system is presumed to comply with the measures set out in this regulation.
- → Article 72: High-risk AI systems must follow the risk management rules set out in Article 72, including implementing a post-market monitoring system.
- → Article 13: The high-risk AI system requires documentation as specified in Article 13.
- ← training data sets: Training data sets must be documented to ensure they meet the governance and management practices for high-risk AI systems.
- ← validation data sets: Validation data sets must be documented to ensure they meet the governance and management practices for high-risk AI systems.
- ← testing data sets: Testing data sets must be documented to ensure they meet the governance and management practices for high-risk AI systems.
- → personal data: The high-risk AI system requires documentation on the processing of personal data to ensure compliance with regulations.
- → safeguards: The high-risk AI system includes safeguards to protect personal data during processing.
- → technical limitations: The high-risk AI system requires documentation of technical limitations on the re-use of personal data.
- → Annex IV: High-risk AI systems require a single set of technical documentation as specified in Annex IV.
- → Section A of Annex I: High-risk AI systems are related to products covered by the Union harmonisation legislation listed in Section A of Annex I.
- → Article 9(2): Article 9(2) lays down rules regarding the safety and fundamental rights related to high-risk AI systems.
- → Article 14: Article 14 requires documentation on the design and development of high-risk AI systems for effective human oversight.
- → Article 12: Article 12 requires mechanisms for logging and interpreting data related to high-risk AI systems.
- ← OJ L, 12.7.2024: The regulation concerning high-risk AI systems was published on this date.
- → Article 43: The high-risk AI system must comply with the conformity assessment procedure outlined in Article 43.
- → Article 47: The high-risk AI system must draw up an EU declaration of conformity as per Article 47.
- → Article 48: The high-risk AI system must affix the CE marking in accordance with Article 48.
- → Article 49(1): The high-risk AI system must comply with registration obligations as stated in Article 49(1).
- → Article 20: The high-risk AI system must take corrective actions as required in Article 20.
- → Directive (EU) 2016/2102: The high-risk AI system must comply with accessibility requirements set by Directive (EU) 2016/2102.
- → Directive (EU) 2019/882: The high-risk AI system must comply with accessibility requirements set by Directive (EU) 2019/882.
- ← Quality management system: The quality management system must be documented to ensure compliance for the high-risk AI system.
- → Article 9: The high-risk AI system must comply with the risk management system outlined in Article 9.
- → Article 73: The high-risk AI system must follow procedures for reporting serious incidents as stated in Article 73.
- ← data management systems: Data management systems are necessary for the operation and compliance of high-risk AI systems.
- ← accountability framework: The accountability framework is essential for defining responsibilities related to high-risk AI systems.
- → Article 12(1): The high-risk AI system must comply with the requirements outlined in Article 12(1) regarding access to logs.
- ← competent authority: The competent authority can request documentation related to the high-risk AI system, including access to logs.
- ← provider: The provider must ensure that the high-risk AI system complies with the regulation.
- ← competent authority: The competent authority cooperates with the provider in ensuring compliance and mitigating risks.
- → Regulation 2024/1689: High-risk AI systems must comply with the requirements set out in Regulation 2024/1689.
- → technical documentation: The high-risk AI system requires technical documentation to be made available to authorities.
- ← distributors: Distributors must ensure compliance with the obligations set out in Article 24 regarding high-risk AI systems.
- ← Article 24: Article 24 specifically addresses the obligations of distributors concerning high-risk AI systems.
- → Section 2: High-risk AI systems must comply with the requirements set out in Section 2.
- → Article 79(1): Article 79(1) outlines the conditions under which a high-risk AI system is deemed non-compliant.
- ← deployer: The deployer monitors the operation of the high-risk AI system based on the provider's instructions.
- ← provider: The provider supplies the high-risk AI system to the deployer.
- ← notified body: Notified bodies are responsible for performing conformity assessments related to high-risk AI systems.
- → national competent authority: The high-risk AI system requires confirmation from the national competent authority regarding health and safety risks.
- → Annex VII: High-risk AI systems must comply with the conformity assessment procedures outlined in Annex VII.
- ← Union institutions, bodies, offices or agencies: These entities may utilize high-risk AI systems for their operations.
- → Annex III: Annex III categorizes high-risk AI systems that must follow specific procedures.
- → Annex VI: Annex VI describes the internal control conformity assessment procedure for high-risk AI systems.
- → Section 2: Section 2 outlines specific requirements that high-risk AI systems must adhere to.
- ← market surveillance authority: The market surveillance authority issues authorizations for high-risk AI systems based on compliance with regulatory requirements.
- ← Member States: Member States can raise objections against authorizations issued by other Member States regarding high-risk AI systems.
- → sensitive operational data: The obligation to inform the Commission does not cover sensitive operational data related to law-enforcement activities.
- ← provider: The provider must perform necessary investigations related to the high-risk AI system involved in the serious incident.
- ← market surveillance authority: The market surveillance authority can restrict or prohibit the availability of high-risk AI systems on the market.
- ← Article 86: Article 86 addresses the implications of high-risk AI systems on individual rights and market practices.
high-risk AI system for post-remote biometric identification
An AI system classified as high-risk that is used for biometric identification from a distance, particularly in law enforcement contexts.
- → Regulation (EU) 2016/679: The use of high-risk AI systems must comply with Regulation (EU) 2016/679 regarding personal data processing.
- → Directive (EU) 2016/680: The use of high-risk AI systems must comply with Directive (EU) 2016/680 concerning the processing of biometric data.
- → market surveillance authority: Deployers must document the use of high-risk AI systems and make this information available to the market surveillance authority.
- → national data protection authority: Deployers must provide documentation on the use of high-risk AI systems to the national data protection authority upon request.
- ← Member States: Member States may introduce more restrictive laws regarding the use of high-risk AI systems.
high-risk AI systems
High-risk AI systems are those identified as posing significant risks to health, safety, and fundamental rights, requiring stringent regulatory oversight and compliance measures.
- ← Union legal framework: The Union legal framework establishes rules for the development and use of high-risk AI systems.
- → internal market: The regulation of high-risk AI systems impacts the functioning of the internal market.
- ← Regulation: The Regulation includes provisions for high-risk AI systems, ensuring affected persons can obtain explanations for decisions based on these systems.
- → Union market: High-risk AI systems should only be placed on the Union market if they meet mandatory requirements.
- ← Regulation (EU) 2019/2144: This regulation establishes mandatory requirements for high-risk AI systems.
- → Regulation (EU) 2017/745: High-risk AI systems must comply with the criteria and safety component requirements established in Regulation (EU) 2017/745.
- → Regulation (EU) 2017/746: High-risk AI systems are classified and must comply with the criteria and safety component requirements set forth in Regulation (EU) 2017/746.
- ← Regulation: The Regulation establishes criteria, mandatory requirements, and rules for identifying and managing high-risk AI systems to ensure trustworthiness and protect fundamental rights.
- ← Commission: The Commission is responsible for proposing amendments and regulations regarding the classification and use of high-risk AI systems.
- → right to education and training: High-risk AI systems may violate the right to education and training.
- → right not to be discriminated against: High-risk AI systems may perpetuate discrimination against various groups.
- ← Commission Work Programme 2021: The document proposes meaningful involvement of employees in AI systems affecting work-related relationships.
- → judicial authority: High-risk AI systems are intended to be used by judicial authorities to assist in legal processes.
- → alternative dispute resolution bodies: High-risk AI systems may also be used by alternative dispute resolution bodies for legal proceedings.
- ← provider: Providers must ensure that high-risk AI systems are managed in accordance with regulations and designed with oversight measures before market placement.
- ← users: The deployment of high-risk AI systems by users can significantly affect the market dynamics.
- → Regulation: High-risk AI systems must comply with the requirements set forth in the applicable regulations.
- → transparency requirements: High-risk AI systems must include transparency requirements to ensure users understand their functionality.
- → technical robustness: High-risk AI systems require documentation of technical robustness measures to ensure safety.
- → European Parliament and Council Regulation: High-risk AI systems can demonstrate compliance with cybersecurity requirements by fulfilling the essential requirements of the regulation.
- ← Regulation (EU) 2024/1689: The regulation lays down rules applicable to high-risk AI systems.
- ← Regulation (EU) 2017/745: Regulation (EU) 2017/745 continues to apply to high-risk AI systems that are classified as medical devices.
- ← General-purpose AI systems: General-purpose AI systems may be used as high-risk AI systems or as components of other high-risk AI systems.
- ← AI value chain: The AI value chain includes multiple parties that supply components and services for high-risk AI systems.
- ← model training: Model training is a computational process used in the development of high-risk AI systems.
- ← model retraining: Model retraining is a computational process that updates high-risk AI systems with new data.
- ← model testing: Model testing is a computational process that evaluates the performance of high-risk AI systems.
- ← model evaluation: Model evaluation is a computational process that assesses the effectiveness of high-risk AI systems.
- → deployers: Deployers of high-risk AI systems must ensure proper documentation and monitoring.
- → Union law: High-risk AI systems must comply with Union law and regulations.
- → national law: High-risk AI systems must also comply with relevant national laws.
- → natural persons: The deployment of high-risk AI systems influences decisions that affect the health, safety, and rights of natural persons.
- → Directive (EU) 2016/680: High-risk AI systems used for law enforcement must comply with the obligations set forth in Directive (EU) 2016/680.
- → fundamental rights impact assessment: High-risk AI systems require a fundamental rights impact assessment to identify risks before deployment.
- ← OJ L, 12.7.2024: The regulation concerning high-risk AI systems was published in the official journal on 12.7.2024.
- → Regulation (EU) 2019/881: High-risk AI systems must comply with the requirements set out in Regulation (EU) 2019/881.
- → conformity assessment: High-risk AI systems are required to undergo a conformity assessment before market placement.
- → notified bodies: High-risk AI systems require third-party conformity assessments by notified bodies.
- ← notified bodies: Notified bodies establish rules and procedures for the conformity assessment of high-risk AI systems.
- → digital CE marking: The regulation lays down rules for the compliance of high-risk AI systems with the digital CE marking.
- ← Member States: Member States must not create obstacles to the market for high-risk AI systems that comply with regulations.
- → EU Database: High-risk AI systems must be registered in the EU database, which involves documentation at the national level.
- → law enforcement: High-risk AI systems are applied in the modality of law enforcement.
- → migration: High-risk AI systems are applied in the modality of migration.
- → asylum: High-risk AI systems are applied in the modality of asylum.
- → border control management: High-risk AI systems are applied in the modality of border control management.
- → critical infrastructure: High-risk AI systems are applied in the modality of critical infrastructure.
- → Regulation: The Regulation lays down rules for the development and testing of high-risk AI systems.
- ← informed consent: Informed consent is required from individuals participating in the testing of high-risk AI systems.
- → post-market monitoring system: High-risk AI systems require a post-market monitoring system to ensure ongoing safety and compliance.
- → Regulation (EU) 2019/1020: High-risk AI systems must adhere to specific documentation requirements as per the regulation.
- ← Directive 2013/36/EU: The directive includes provisions that apply to the monitoring obligations of deployers of high-risk AI systems.
- ← market surveillance authority: Market surveillance authorities are tasked with overseeing compliance related to high-risk AI systems.
- → market surveillance authorities: High-risk AI systems require market surveillance authorities to promote compliance and guidance.
- → ethical and trustworthy AI: The development of AI systems other than high-risk AI systems aims to improve the uptake of ethical and trustworthy AI in the Union.
- ← Article 6: Article 6 outlines the classification rules for identifying high-risk AI systems.
- ← risk management system: The risk management system must be documented and maintained in relation to high-risk AI systems.
- → technical documentation: High-risk AI systems require technical documentation to demonstrate compliance prior to market placement.
- → human oversight: High-risk AI systems must be designed to allow for effective human oversight.
- ← deployer: The deployer implements high-risk AI systems and must ensure that human oversight is maintained.
- → Article 15: High-risk AI systems must be designed to achieve accuracy, robustness, and cybersecurity as outlined in Article 15.
- → Annex III: High-risk AI systems are defined and regulated according to the guidelines set forth in Annex III.
- ← Union or national law: Union or national law may amend the requirements for verification of high-risk AI systems in specific contexts.
- ← OJ L, 12.7.2024: The publication date indicates when the regulation concerning high-risk AI systems was officially released.
- → Article 16: Article 16 outlines the obligations of providers of high-risk AI systems.
- → Article 17: Article 17 specifies the quality management system requirements for high-risk AI systems.
- → Article 18: Article 18 refers to the documentation that must be maintained by providers of high-risk AI systems.
- → Article 19: Article 19 discusses the logs that must be kept for high-risk AI systems.
- → Article 43: Article 43 outlines the conformity assessment procedure for high-risk AI systems.
- → Article 47: Article 47 details the requirements for the EU declaration of conformity for high-risk AI systems.
- → CE marking: High-risk AI systems must have CE marking to indicate compliance with EU regulations.
- → Union financial services law: High-risk AI systems must comply with the obligations and regulations established in Union financial services law.
- ← Article 11: Article 11 outlines the technical documentation required for high-risk AI systems.
- ← Article 17: Article 17 outlines the quality management system documentation required for high-risk AI systems.
- ← Article 47: Article 47 refers to the EU declaration of conformity required for high-risk AI systems.
- ← notified bodies: Notified bodies assess and approve changes related to high-risk AI systems.
- → Article 12(1): High-risk AI systems are required to keep logs as specified in Article 12(1).
- → personal data: High-risk AI systems must comply with laws protecting personal data.
- → market surveillance authorities: Providers must inform market surveillance authorities about non-compliance issues.
- → notified body: Providers must inform the notified body that issued a certificate for the high-risk AI system.
- ← product manufacturer: The product manufacturer is responsible for ensuring that high-risk AI systems comply with the obligations set out in the regulation.
- → Regulation: High-risk AI systems must have necessary documentation to comply with the regulation.
- ← third party: Third parties must provide necessary information and assistance to comply with obligations regarding high-risk AI systems.
- ← Union harmonisation legislation: Union harmonisation legislation impacts the market for high-risk AI systems by establishing compliance standards.
- ← AI Office: The AI Office proposes voluntary model terms for contracts related to high-risk AI systems.
- → Article 26: Article 26 outlines the obligations of deployers of high-risk AI systems.
- → intellectual property rights: The deployment of high-risk AI systems must include safeguards for intellectual property rights.
- → confidential business information: The deployment of high-risk AI systems must include safeguards for confidential business information.
- → trade secrets: The deployment of high-risk AI systems must include safeguards for trade secrets.
- → personal data: High-risk AI systems must comply with regulations regarding the protection of personal data.
- → Article 50: High-risk AI systems must comply with the provisions outlined in Article 50 of the regulation.
- ← Member States: Member States may introduce more restrictive laws regarding the use of high-risk AI systems in accordance with Union law.
- → Annex III: High-risk AI systems are defined and categorized in Annex III, which outlines specific regulations and additional requirements.
- ← notified body: The notified body assesses high-risk AI systems and issues certificates based on compliance.
- ← notifying authority: The notifying authority requires documentation to ensure the conformity of high-risk AI systems.
- ← Commission: The Commission coordinates conformity assessment procedures for high-risk AI systems.
- → Union market: High-risk AI systems placed on the Union market must meet specific regulatory requirements.
- → Article 10(4): High-risk AI systems are presumed to comply with the requirements laid down in Article 10(4).
- → Article 15: High-risk AI systems certified under a cybersecurity scheme are presumed to comply with the requirements in Article 15.
- ← Annex III: Annex III lists the high-risk AI systems that must comply with specific requirements.
- ← Article 43: Article 43 outlines the standard conformity assessment procedures that may be amended for high-risk AI systems.
- ← EU declaration of conformity: The EU declaration of conformity is required for each high-risk AI system to certify compliance.
- ← market surveillance authority: The market surveillance authority has the power to withdraw authorisation for high-risk AI systems deemed unjustified.
- ← EU declaration of conformity: The EU declaration of conformity lays down rules for compliance with legislation applicable to high-risk AI systems.
- ← CE marking: CE marking requires documentation to be affixed visibly and legibly for high-risk AI systems.
- → Article 49: High-risk AI systems must be registered and submit information as required by Article 49.
- → real-world testing plan: High-risk AI systems require a real-world testing plan to be developed and followed during testing.
- ← Article 60: Article 60 specifically addresses the testing procedures for high-risk AI systems.
- ← Article 5: Article 5 proposes prohibitions that must be adhered to during the testing of high-risk AI systems.
- → market surveillance authority: High-risk AI systems must submit a real-world testing plan to the market surveillance authority for oversight.
- → post-market monitoring plan: High-risk AI systems require a documented post-market monitoring plan to evaluate their compliance.
- → Annex I: High-risk AI systems are covered under the Union harmonisation legislation listed in Annex I.
- ← Market surveillance authorities: Market surveillance authorities oversee compliance related to high-risk AI systems.
- ← Regulation (EU) 2019/1020: Regulation that provides a framework for the oversight of high-risk AI systems.
- ← market surveillance authorities: Market surveillance authorities cooperate with the AI Office to evaluate compliance of high-risk AI systems.
- ← AI Office: The AI Office requires documentation to assess compliance of high-risk AI systems.
- ← market surveillance authority: The market surveillance authority is responsible for organizing testing of high-risk AI systems when requested by public authorities.
- → national competent authorities: High-risk AI systems are regulated by national competent authorities to ensure compliance with laws.
- → Annex III: Annex III provides the parameters and criteria for classifying AI systems as high-risk.
Horizon Europe
The EU Research and Innovation programme that aims to support research and innovation across Europe.
- → this Regulation: The programme supports research and innovation that aligns with the goals of the Regulation.
human oversight
Measures designed to ensure that high-risk AI systems can be effectively monitored by natural persons during their use.
- ← high-risk AI systems: High-risk AI systems must be designed to allow for effective human oversight.
- → automation bias: Human oversight aims to mitigate the risks associated with automation bias in high-risk AI systems.
identity checks
Procedures conducted by authorities to verify the identity of individuals, often involving the use of information systems.
- → basic supplies: The conduct of identity checks can impact the provision of basic supplies to the population.
- → core function of the State: Identity checks are essential for maintaining the core functions of the State, including public safety.
immigration authorities
Government bodies that regulate the entry, stay, and exit of foreign nationals in a country.
- ← Regulation: The Regulation outlines the procedures immigration authorities must follow during identity checks.
imminent threat to life
A condition that indicates a serious risk to the life or safety of individuals.
- → natural persons: An imminent threat to life can arise from disruptions to critical infrastructure affecting individuals.
impact assessment
A systematic process to evaluate the potential effects of deploying a high-risk AI system, focusing on risks to fundamental rights and governance arrangements.
- ← high-risk AI system: The deployment of a high-risk AI system necessitates a thorough impact assessment to identify risks and governance measures.
- → natural persons: The impact assessment identifies specific categories of natural persons likely to be affected by the high-risk AI system.
- → civil society organisations: The impact assessment process may involve civil society organisations to ensure comprehensive evaluation and stakeholder engagement.
implementation acts
Acts that may be used by the Commission to approve codes of practice or provide common rules for implementation.
- → codes of practice: Implementation acts may propose the approval of codes of practice if they are not finalized or deemed adequate.
importer
A person or entity in the Union that markets an AI system under the name or trademark of a third-country entity.
- → AI system: The importer places the AI system on the market.
- → AI system: The importer is responsible for placing AI systems on the market.
- → market surveillance authorities: Importers must inform market surveillance authorities if a high-risk AI system is not in conformity.
- → EU declaration of conformity: Importers must keep a copy of the EU declaration of conformity for high-risk AI systems.
- → 10 years: Importers are required to keep documentation for a period of 10 years.
Importers and distributors
Operators in the AI value chain who contribute to the development and distribution of AI systems.
- → High-risk AI systems: Importers and distributors play a role in the market for high-risk AI systems by contributing to their development.
- → High-risk AI system: Importers and distributors must comply with obligations related to high-risk AI systems.
in vitro diagnostic medical devices
Medical devices used for diagnostic purposes outside of the human body, which may be classified as high-risk.
inclusive and diverse design
An approach to AI system development that emphasizes the inclusion of diverse perspectives and stakeholders.
- ← codes of conduct: Codes of conduct may facilitate an inclusive and diverse design of AI systems.
independent administrative authority
An authority that can also grant authorization for the use of biometric identification systems, with binding decisions in the Member State.
innovative AI systems
Artificial intelligence systems that are being developed and tested within the regulatory sandboxes to ensure compliance with relevant laws.
- ← AI regulatory sandbox: The AI regulatory sandbox provides a controlled environment for the development and testing of innovative AI systems.
Instructions for use
Documentation that accompanies high-risk AI systems, detailing their characteristics, capabilities, limitations, and usage guidelines.
- ← High-risk AI systems: High-risk AI systems must be accompanied by instructions for use that outline their characteristics and limitations.
- → Deployer: Instructions for use are intended for deployers to assist them in making informed decisions about the AI system.
- → Member State: Instructions for use must be made available in a language determined by the Member State to ensure understanding by deployers.
intellectual property rights
Legal rights that protect the creations of the mind, which must be observed in the context of AI systems.
- ← high-risk AI systems: The deployment of high-risk AI systems must include safeguards for intellectual property rights.
interdisciplinary cooperation
Collaboration between AI developers and experts from various fields to address issues related to inequality, non-discrimination, and digital rights.
- → AI developers: Interdisciplinary cooperation acts in accordance with the needs of AI developers and other experts.
Interinstitutional Agreement of 13 April 2016
An agreement that outlines the principles for better law-making within the European Union.
- ← Commission: The Commission consults experts in accordance with the principles laid down in the Interinstitutional Agreement.
Interinstitutional Agreement of 13 April 2016 on Better Law-Making
An agreement that outlines principles for better law-making within the EU, ensuring transparency and equal participation.
- → European Commission: The agreement includes safeguards for equal participation in the preparation of delegated acts.
internal and/or external adversarial testing
Testing methods such as red teaming to identify vulnerabilities in AI models.
internal market
The internal market of the EU facilitates the free movement of goods and services among member states, impacting the deployment of AI models.
- ← high-risk AI systems: The regulation of high-risk AI systems impacts the functioning of the internal market.
internal processes
Operations within an organization that do not involve providing products or services to third parties.
- ← general-purpose AI models: General-purpose AI models do not apply obligations when used solely for internal processes that do not affect third parties.
international organisations
Entities established by treaties between multiple countries that may operate internationally and use AI systems in cooperation with the Union.
- → Regulation: International organisations may also be exempt from the regulation when acting under cooperation agreements.
- ← Regulation (EU) 2024/1689: The regulation includes safeguards for international organisations using AI systems.
international partners
Organizations and entities outside the EU that collaborate on metrology and measurement indicators related to AI.
- ← Commission: The Commission collaborates with international partners on metrology and measurement indicators related to AI.
Ireland
A member state of the European Union that is referenced in the context of data protection regulations.
judicial authority
An independent authority that grants prior authorization for the use of biometric identification systems, ensuring compliance with legal standards.
large generative AI models
A subset of general-purpose AI models capable of generating diverse content such as text, audio, images, or video.
- → self-supervision: Large generative AI models utilize self-supervision to learn from vast datasets, enhancing their capabilities.
- ← artists, authors, and other creators: The emergence of large generative AI models presents both opportunities and challenges for creators in the market.
law enforcement
This modality involves the application of law by authorities to maintain public order, utilizing AI systems for enforcement and public safety.
- ← 2024/1689: The regulation addresses the use of AI systems in the context of law enforcement.
- ← AI systems: AI systems may also be applied in law enforcement activities.
- ← AI system: AI systems intended for law enforcement are included under the Regulation's scope.
- ← AI systems for social scoring: These AI systems may be used in the context of law enforcement, impacting rights and freedoms.
- ← AI systems for remote biometric identification: The use of AI systems for biometric identification impacts the market for law enforcement activities.
- ← high-risk AI systems: High-risk AI systems are applied in the modality of law enforcement.
- → serious incident: Law enforcement activities may be influenced by serious incidents involving AI systems.
- → biometric data: Law enforcement agencies are subject to specific rules regarding the use of biometric data in public spaces.
- ← Annex II: The offences listed in Annex II affect the operations and regulations of law enforcement agencies.
- ← real-time remote biometric identification systems: These AI systems are used in accordance with laws governing law enforcement activities.
law enforcement
Uses of AI systems for maintaining public order and safety, which are included in the scope of the Regulation.
- ← 2024/1689: The regulation addresses the use of AI systems in the context of law enforcement.
- ← AI systems: AI systems may also be applied in law enforcement activities.
- ← AI system: AI systems intended for law enforcement are included under the Regulation's scope.
- ← AI systems for social scoring: These AI systems may be used in the context of law enforcement, impacting rights and freedoms.
- ← AI systems for remote biometric identification: The use of AI systems for biometric identification impacts the market for law enforcement activities.
- ← high-risk AI systems: High-risk AI systems are applied in the modality of law enforcement.
- → serious incident: Law enforcement activities may be influenced by serious incidents involving AI systems.
- → biometric data: Law enforcement agencies are subject to specific rules regarding the use of biometric data in public spaces.
- ← Annex II: The offences listed in Annex II affect the operations and regulations of law enforcement agencies.
- ← real-time remote biometric identification systems: These AI systems are used in accordance with laws governing law enforcement activities.
law enforcement
Law enforcement encompasses agencies responsible for enforcing laws, maintaining public order, and preventing and investigating crimes, potentially using AI systems.
- ← 2024/1689: The regulation addresses the use of AI systems in the context of law enforcement.
- ← AI systems: AI systems may also be applied in law enforcement activities.
- ← AI system: AI systems intended for law enforcement are included under the Regulation's scope.
- ← AI systems for social scoring: These AI systems may be used in the context of law enforcement, impacting rights and freedoms.
- ← AI systems for remote biometric identification: The use of AI systems for biometric identification impacts the market for law enforcement activities.
- ← high-risk AI systems: High-risk AI systems are applied in the modality of law enforcement.
- → serious incident: Law enforcement activities may be influenced by serious incidents involving AI systems.
- → biometric data: Law enforcement agencies are subject to specific rules regarding the use of biometric data in public spaces.
- ← Annex II: The offences listed in Annex II affect the operations and regulations of law enforcement agencies.
- ← real-time remote biometric identification systems: These AI systems are used in accordance with laws governing law enforcement activities.
law enforcement authorities
Law enforcement authorities are government agencies responsible for maintaining public order and enforcing laws, which may utilize AI systems in their operations.
- ← Regulation: The Regulation establishes guidelines for how law enforcement authorities can conduct identity checks.
- → real-time remote biometric identification systems: Law enforcement authorities utilize biometric identification systems to confirm identities during checks.
- ← AI systems: AI systems are intended for use by law enforcement authorities in critical decision-making situations.
- → Union institutions: Union institutions provide support to law enforcement authorities.
- ← polygraphs: Polygraphs are used by law enforcement authorities to evaluate evidence reliability.
law enforcement authority
A law enforcement authority is responsible for maintaining public order and enforcing laws, requiring authorization for the use of biometric identification systems.
- → real-time remote biometric identification system: The law enforcement authority must authorize the use of the biometric identification system.
- → national law: The law enforcement authority must act in accordance with national law when using biometric identification systems.
- → real-time biometric identification systems: The law enforcement authority must provide reasons for not requesting authorization for the use of biometric systems.
- ← AI Office: The AI Office contributes to the implementation and monitoring of AI systems, which may include law enforcement authorities.
law-enforcement authorities
Authorities responsible for maintaining public order and safety, which may act in urgent situations regarding high-risk AI systems.
- → specific high-risk AI systems: Law-enforcement authorities may act in accordance with regulations to put specific high-risk AI systems into service without prior authorization in urgent situations.
logging methods
Techniques for recording the generation and manipulation of content.
- ← AI systems: AI systems are expected to use logging methods to track content generation.
logic- and knowledge-based approaches
Approaches that allow AI systems to infer from encoded knowledge or symbolic representations.
- ← AI system: AI systems also incorporate logic- and knowledge-based approaches for inference.
logs
Records generated by the AI system that document verifications and operations performed by users.
M. Michel
The President of the Council of the European Union who signed the regulation.
machine learning approaches
Techniques that enable AI systems to learn from data to achieve specific objectives.
- ← AI system: AI systems utilize machine learning approaches as part of their inference capabilities.
machine-brain interfaces
Technological systems that connect directly with the human brain to influence behavior through stimuli.
machinery
Products designed for mechanical work, which may be classified as high-risk under certain regulations.
mandate
A written document that specifies the tasks assigned to the authorised representative by the provider.
- ← authorised representative: The tasks of the authorised representative are defined by the mandate received from the provider.
manipulative or exploitative AI-enabled practices
Practices involving AI systems that can lead to harmful outcomes for users.
- → significant harm: These practices can lead to significant harm, even without the intention to do so.
market surveillance authorities
Authorities responsible for enforcing compliance with regulations, ensuring product safety, and monitoring high-risk AI systems in the market.
- ← Board: The Board establishes sub-groups for cooperation among market surveillance authorities.
- → Regulation: Market surveillance authorities act in accordance with the provisions laid down in the Regulation.
- → Directive (EU) 2016/680: Market surveillance authorities act in accordance with the powers conferred by Directive (EU) 2016/680.
- → Regulation (EU) 2019/1020: Market surveillance authorities are guided by Article 9 of Regulation (EU) 2019/1020 for compliance activities.
- ← high-risk AI systems: High-risk AI systems require market surveillance authorities to promote compliance and guidance.
- → AI Office: Market surveillance authorities can request assistance from the AI Office for investigations related to high-risk AI systems.
- ← high-risk AI systems: Providers must inform market surveillance authorities about non-compliance issues.
- ← importer: Importers must inform market surveillance authorities if a high-risk AI system is not in conformity.
- ← notified body: Notified bodies must inform market surveillance authorities about conformity assessment activities.
- ← competent authority: The competent authority provides exit reports to market surveillance authorities to assist in conformity assessment.
- ← Member States: Member States confer powers to market surveillance authorities to oversee AI system compliance.
- → AI system: Market surveillance authorities regulate high-risk AI systems, impacting their market presence.
- ← Article 60: Article 60 specifies that certain information in the EU database is accessible only to market surveillance authorities.
- ← providers of high-risk AI systems: Providers must report serious incidents to the market surveillance authorities.
- → Commission: Market surveillance authorities report annually to the Commission about market surveillance activities.
- → high-risk AI systems: Market surveillance authorities cooperate with the AI Office to evaluate compliance of high-risk AI systems.
- → Article 76: Market surveillance authorities are governed by the provisions outlined in Article 76.
- → Annex IV: Market surveillance authorities require access to technical documentation as outlined in Annex IV.
- → Article 74: Article 74 outlines the obligations of market surveillance authorities in relation to high-risk AI systems.
- → Regulation (EU) 2019/1020: Market surveillance authorities act in accordance with the provisions set out in Regulation (EU) 2019/1020.
- ← Article 18: Article 18 outlines the procedural rights of operators, which market surveillance authorities must consider.
- → operator: Market surveillance authorities may apply administrative fines to operators for infringements.
market surveillance authority
A regulatory authority within each Member State responsible for monitoring and ensuring compliance with market regulations, particularly concerning high-risk AI systems and biometric identification, to uphold safety and standards.
- ← real-time biometric identification systems: The relevant market surveillance authority must be notified of each use of the biometric identification system.
- ← high-risk AI system: After conducting the impact assessment, the deployer must notify the relevant market surveillance authority.
- ← Member States: Each Member State should designate a market surveillance authority to act as a single point of contact.
- → high-risk AI systems: Market surveillance authorities are tasked with overseeing compliance related to high-risk AI systems.
- → personal data: Market surveillance authorities have the power to access personal data necessary for their investigative tasks.
- ← natural and legal persons: Natural and legal persons can lodge complaints with the relevant market surveillance authority regarding infringements of the Regulation.
- → Regulation (EU) 2019/1020: Market surveillance authorities operate in accordance with Regulation (EU) 2019/1020 to ensure compliance.
- ← real-time remote biometric identification system: The use of the biometric identification system must be notified to the market surveillance authority.
- ← deployer: The deployer must inform the market surveillance authority about serious incidents and the results of their assessments related to the AI system.
- ← high-risk AI system for post-remote biometric identification: Deployers must document the use of high-risk AI systems and make this information available to the market surveillance authority.
- → notification template: The market surveillance authority requires the notification template to be submitted by the deployer.
- → high-risk AI system: The market surveillance authority issues authorizations for high-risk AI systems based on compliance with regulatory requirements.
- → high-risk AI systems: The market surveillance authority has the power to withdraw authorisation for high-risk AI systems deemed unjustified.
- ← high-risk AI systems: High-risk AI systems must submit a real-world testing plan to the market surveillance authority for oversight.
- → real-world testing plan: The market surveillance authority must approve the real-world testing plan before testing can commence.
- ← testing in real world conditions: Providers must notify the market surveillance authority about extensions for testing.
- → Article 19: The market surveillance authority acts in accordance with the procedures outlined in Article 19 of Regulation (EU) 2019/1020.
- → national public authorities: The market surveillance authority informs and cooperates with national public authorities regarding serious incidents and risks to fundamental rights.
- → Union harmonisation legislation: The market surveillance authority operates under the guidelines set by the Union harmonisation legislation.
- ← Regulation (EU) 2019/1020: Regulation (EU) 2019/1020 establishes the framework and rules for the operation of market surveillance authorities.
- ← Articles 79 to 83: These articles outline the procedures that the market surveillance authority must follow.
- ← Article 14: Article 14 provides specific powers and safeguards for the market surveillance authority to enforce regulations.
- → Regulation: The market surveillance authority operates under the guidelines set by the Regulation.
- ← Regulation (EU) 2016/679: The Regulation includes safeguards for data protection that the market surveillance authority must enforce.
- ← Directive (EU) 2016/680: The Directive provides additional safeguards that the market surveillance authority must consider.
- ← Article 77: Article 77 grants powers to national public authorities to request documentation from the market surveillance authority.
- → high-risk AI systems: The market surveillance authority is responsible for organizing testing of high-risk AI systems when requested by public authorities.
- → AI systems: The market surveillance authority evaluates and monitors AI systems in accordance with Regulation (EU) 2019/1020.
- → vulnerable groups: The market surveillance authority must pay particular attention to vulnerable groups during evaluations.
- → AI system: The market surveillance authority proposes measures to prohibit or restrict the AI system's availability on the market if non-compliance is detected.
- → AI system: The market surveillance authority evaluates AI systems classified as non-high-risk to determine if they are high-risk.
- → Article 80: The actions of the market surveillance authority are guided by the procedures outlined in Article 80.
- ← Union safeguard procedure: The Union safeguard procedure involves consultation with the market surveillance authority.
- → high-risk AI system: The market surveillance authority can restrict or prohibit the availability of high-risk AI systems on the market.
medical devices
Products used for medical purposes that may be classified as high-risk under certain regulations.
Member State
A member state is a country within the European Union that implements national laws and regulations, including those related to biometric identification systems.
- → Regulation: Member States must act in accordance with the Regulation when deciding on the use of biometric identification systems.
- ← Instructions for use: Instructions for use must be made available in a language determined by the Member State to ensure understanding by deployers.
- → High-risk AI systems: Member States establish rules regarding the oversight and operational constraints of high-risk AI systems.
- → Commission: Member States must notify the Commission of the rules regarding the use of biometric identification systems.
- → real-time remote biometric identification system: Member States lay down national laws governing the use of biometric identification systems.
- → Article 21: Member States provide official languages for communication as per Article 21.
- ← Notified Bodies: Notified bodies are required to communicate with the notifying authorities of the Member State.
- → national competent authorities: Member States have national competent authorities that oversee the management of certificates.
- → Commission: A Member State must inform the Commission if it believes that a common specification does not meet the required standards.
- ← Certificates: Certificates must be drawn up in a language understood by the relevant authorities in the Member State.
- → specific high-risk AI systems: Member States may propose the authorization of specific high-risk AI systems for market placement under exceptional circumstances.
- ← Commission: The Commission notifies the relevant Member State of its decisions and findings regarding AI systems.
- ← Union safeguard procedure: The Union safeguard procedure proposes actions to be taken when objections are raised by a Member State.
- → AI practices: Member States must take appropriate measures regarding AI practices if deemed justified by the Commission.
- → Commission: Member States provide their findings and opinions to the Commission regarding AI systems.
- → Regulation: Member States are required to establish rules regarding the imposition of administrative fines as per the regulation.
Member States
Countries that are members of the European Union, responsible for implementing EU regulations and ensuring compliance with AI-related laws.
- → third country: Member States may establish bilateral agreements with third countries for law enforcement and judicial cooperation.
- ← Article 4(2) TEU: Article 4(2) TEU outlines the responsibilities of Member States regarding national security.
- ← Chapter 2 of Title V TEU: This chapter addresses the common Union defense policy that Member States must adhere to.
- → high-risk AI systems: Member States must not create obstacles to the market for high-risk AI systems that comply with regulations.
- → AI regulatory sandbox: Member States are responsible for establishing AI regulatory sandboxes to facilitate AI innovation at the national level.
- → AI system: Member States are encouraged to support and promote the development of AI solutions for beneficial outcomes.
- → SMEs: Member States propose initiatives targeted at SMEs to support their development and innovation.
- → AI regulatory sandboxes: Member States provide AI regulatory sandboxes for SMEs to test their AI systems.
- → SMEs: Member States should facilitate the participation of SMEs in standardisation development processes.
- → start-ups: Member States should take into account the specific interests of start-ups when setting conformity assessment fees.
- ← Commission: The Commission should work with Member States to lower certification and compliance costs for SMEs.
- → this Regulation: Member States are responsible for implementing and transmitting the Regulation's requirements.
- ← Board: The Board is composed of representatives from Member States.
- → Scientific Panel: Member States can request support from the Scientific Panel for enforcement activities.
- → Regulation: Member States are required to apply and enforce the Regulation, including implementing rules on penalties.
- → scientific panel: Member States can request support from the scientific panel for enforcement activities.
- → market surveillance authority: Each Member State should designate a market surveillance authority to act as a single point of contact.
- ← Regulation (EU) 2023/988: The regulation sets rules that Member States must follow to ensure compliance and enforcement.
- → European Data Protection Supervisor: Member States must report compliance and enforcement actions to the European Data Protection Supervisor.
- ← European Data Protection Supervisor: The European Data Protection Supervisor provides opinions on the implementation of the regulation by Member States.
- ← Regulation (EU) No 182/2011: The regulation is designed to be exercised in accordance with Member States' control mechanisms.
- → Regulation: Member States retain competences that may affect the implementation of the regulation in relation to national security.
- ← Regulation (EU) 2024/1689: The regulation affects the market by defining the scope of AI systems that Member States can regulate.
- → AI systems: Member States may propose laws that are more favorable to workers regarding AI systems.
- → Commission: Member States must submit annual reports on biometric identification systems and the status of their national competent authorities to the Commission.
- → high-risk AI system for post-remote biometric identification: Member States may introduce more restrictive laws regarding the use of high-risk AI systems.
- → high-risk AI systems: Member States may introduce more restrictive laws regarding the use of high-risk AI systems in accordance with Union law.
- ← notifying authorities: Notifying authorities notify other Member States about conformity assessment bodies.
- ← Commission: The Commission communicates its decisions regarding the authorization of notified bodies to Member States.
- → notified body: Member States require notified bodies to provide documentary evidence and accreditation certificates.
- ← notifying authority: The notifying authority informs other Member States about the suspension or withdrawal of designations.
- → high-risk AI system: Member States can raise objections against authorizations issued by other Member States regarding high-risk AI systems.
- → 15 calendar days: Member States have a period of 15 calendar days to raise objections regarding authorizations.
- ← AI regulatory sandboxes: The establishment of AI regulatory sandboxes affects the market by providing a controlled environment for AI innovation.
- → market surveillance authorities: Member States confer powers to market surveillance authorities to oversee AI system compliance.
- → AI Office: Member States shall facilitate the tasks entrusted to the AI Office as reflected in the regulation.
- ← European Artificial Intelligence Board: The Board is composed of one representative per Member State.
- → European Artificial Intelligence Board: Member States designate representatives to the Board for a period of three years.
- ← Board: The Board operates in accordance with the rules adopted by the Member States.
- ← AI Office: The AI Office assists Member States in developing AI regulatory sandboxes.
- → Regulation 2024/1689: Member States are involved in the implementation of Regulation 2024/1689.
- → scientific panel: Member States may call upon experts from the scientific panel to support their enforcement activities under the Regulation.
- ← Commission: The Commission facilitates access to experts for Member States as needed.
- → national competent authorities: Member States shall establish or designate national competent authorities to serve as single points of contact for the Regulation.
- → Article 70: Article 70 outlines the requirements for national competent authorities.
- → 2 August 2025: By August 2, 2025, Member States must publicly provide information on their designated competent authorities as part of their obligations under the Regulation.
- → national competent authority: Member States designate national competent authorities for reporting serious incidents.
- ← Market Surveillance Authority: The market surveillance authority communicates decisions, non-compliance issues, and evaluation results of AI systems to other Member States.
- → public authorities or bodies: Member States are required to identify and make publicly available the list of public authorities or bodies overseeing high-risk AI systems.
- ← Regulation (EU) 2019/1020: The regulation lays down rules that Member States must follow regarding the evaluation of AI systems.
- → codes of conduct: Member States assist in the drawing up of codes of conduct for AI systems.
- → AI system: Member States regulate the placement of AI systems on the market within the EU.
metrology and benchmarking authorities
Organizations that focus on measurement standards and benchmarks, particularly in the context of AI systems.
- ← Commission: The Commission collaborates with metrology and benchmarking authorities to develop benchmarks for AI systems.
microenterprises
Small businesses that may be exempt from certain regulations regarding the use of personal data.
- ← personal data: Transactions between microenterprises are exempt from certain regulations regarding the use of personal data.
- ← Commission: The Commission proposes guidelines for microenterprises to establish a quality management system.
microenterprises
Small businesses that may face challenges in fulfilling regulatory obligations due to their size and resources.
- ← personal data: Transactions between microenterprises are exempt from certain regulations regarding the use of personal data.
- ← Commission: The Commission proposes guidelines for microenterprises to establish a quality management system.
migration
An area of application for high-risk AI systems that involves the management of migration processes.
military purposes
Uses of AI systems that are specifically excluded from the scope of the Regulation.
- ← Regulation: The Regulation explicitly excludes military, defense, and national security uses of AI systems.
Modalities
Different types of input and output formats for AI models, such as text-to-text or text-to-image.
modality
The types of input and output formats that an AI model can handle, such as text or image.
model and data cards
Documentation tools that provide essential information about AI models and datasets, promoting transparency and understanding.
model cards
Documentation practices that provide information about AI models to promote transparency and trustworthiness.
- → AI system: Model cards are recommended documentation practices for AI systems to enhance transparency.
model evaluation
The assessment of an AI model's effectiveness and accuracy.
- → high-risk AI systems: Model evaluation is a computational process that assesses the effectiveness of high-risk AI systems.
model evaluations
Processes required to assess the performance and risks associated with AI models.
model retraining
The process of updating an AI model with new data to improve its performance.
- → high-risk AI systems: Model retraining is a computational process that updates high-risk AI systems with new data.
model testing
The evaluation of an AI model's performance using a separate dataset.
- → high-risk AI systems: Model testing is a computational process that evaluates the performance of high-risk AI systems.
model training
The process of teaching an AI model to make predictions or decisions based on data.
- → high-risk AI systems: Model training is a computational process used in the development of high-risk AI systems.
mutual recognition agreements
Agreements aimed at recognizing conformity assessment results across different jurisdictions.
- ← Commission: The Commission should actively explore and pursue mutual recognition agreements with third countries.
Mutual recognition agreements
Agreements aimed at facilitating trade and cooperation between the EU and third countries.
- ← Regulation: The Regulation proposes the conclusion of mutual recognition agreements with third countries.
national authorities
National authorities that are granted access to the restricted sections of the EU database.
- → EU database: National authorities have an opinion on the access to the restricted sections of the EU database.
national competent authorities
National bodies designated to ensure compliance with AI regulations and oversee the implementation of laws within their jurisdictions.
- ← general-purpose AI model: The provider must also make technical documentation available to national competent authorities upon request.
- ← general-purpose AI models: Providers must transmit relevant information about incidents to national competent authorities.
- → notified bodies: National competent authorities notify notified bodies under the regulation.
- ← AI regulatory sandbox: The AI regulatory sandbox should cooperate with national competent authorities to ensure effective supervision.
- → fundamental rights: National competent authorities supervise the protection of fundamental rights in the context of AI systems.
- → Union law: National competent authorities supervise the application of Union law protecting fundamental rights.
- ← Article 18: Article 18 requires providers to keep documentation available for national competent authorities.
- ← notifying authority: The notifying authority provides relevant information about certificates to national competent authorities.
- ← certificates: Providers must provide relevant information about certificates to the national competent authorities.
- ← Member State: Member States have national competent authorities that oversee the management of certificates.
- ← AI regulatory sandboxes: National competent authorities are involved in the operation and supervision of AI regulatory sandboxes.
- → personal data: National competent authorities ensure compliance with regulations regarding the processing of personal data in AI systems.
- ← Member States: Member States shall establish or designate national competent authorities to serve as single points of contact for the Regulation.
- → Regulation: National competent authorities ensure the application and implementation of the Regulation.
- → Regulation: National competent authorities must operate under the guidelines set by the Regulation.
- → Article 78: National competent authorities must adhere to the confidentiality obligations outlined in Article 78.
- ← Commission: The Commission facilitates the exchange of experience between national competent authorities.
- → Regulation: National competent authorities may provide guidance and advice on the implementation of the Regulation.
- → Commission: National competent authorities exchange information with the Commission regarding AI systems.
- ← high-risk AI systems: High-risk AI systems are regulated by national competent authorities to ensure compliance with laws.
- ← operator: Operators must cooperate with national competent authorities to remedy infringements.
national competent authority
The designated authority in each Member State responsible for overseeing AI system compliance and handling serious incident notifications.
- → AI Office: National competent authorities transmit information regarding AI systems to the AI Office.
- ← high-risk AI system: The high-risk AI system requires confirmation from the national competent authority regarding health and safety risks.
- ← Member States: Member States designate national competent authorities for reporting serious incidents.
- → Commission: National competent authorities must notify the Commission of serious incidents.
national data protection authority
This authority oversees data protection laws and ensures compliance with regulations regarding personal data at the national level.
national law
National law refers to the legal framework established by individual countries that governs the use of biometric identification systems and other regulations.
- ← law enforcement authority: The law enforcement authority must act in accordance with national law when using biometric identification systems.
- ← high-risk AI systems: High-risk AI systems must also comply with relevant national laws.
- ← Article 78: Article 78 requires compliance with national law regarding confidentiality.
national law
The body of laws and regulations that govern individual member states of the European Union.
- ← law enforcement authority: The law enforcement authority must act in accordance with national law when using biometric identification systems.
- ← high-risk AI systems: High-risk AI systems must also comply with relevant national laws.
- ← Article 78: Article 78 requires compliance with national law regarding confidentiality.
national public authorities
Government bodies at the national level that may be involved in the oversight and regulation of AI systems.
- ← market surveillance authority: The market surveillance authority informs and cooperates with national public authorities regarding serious incidents and risks to fundamental rights.
natural person
An individual whose risk of becoming a victim or offender is assessed using AI systems.
- ← AI systems: AI systems assess the risk of natural persons becoming victims or offenders.
natural persons
Individuals whose fundamental rights and freedoms are protected under the regulation and who may be affected by AI systems.
- ← Regulation: The regulation aims to protect the fundamental rights and freedoms of natural persons located in the Union.
- ← AI systems for social scoring: AI systems for social scoring evaluate natural persons, potentially leading to discriminatory outcomes.
- ← remote biometric identification: This modality can intrusively identify natural persons, affecting their rights and freedoms.
- ← Union and national law: These laws govern the lawful evaluation practices of natural persons, ensuring their rights are protected.
- ← real-time remote biometric identification systems: The use of biometric identification systems can impact the safety and privacy of individuals.
- ← imminent threat to life: An imminent threat to life can arise from disruptions to critical infrastructure affecting individuals.
- → AI systems: Natural persons should not be judged based on AI systems' predictions without human assessment.
- → public assistance benefits: Natural persons depend on public assistance benefits and services from authorities.
- ← AI systems: AI systems determine the granting or denial of benefits to natural persons.
- ← credit score evaluation: AI systems evaluating credit scores affect natural persons' access to financial resources.
- ← AI systems: AI systems used in migration and border control management can significantly impact the treatment of vulnerable natural persons in the market.
- ← competent public authorities: Competent public authorities require documentation from natural persons applying for asylum, visa, and residence permits.
- ← High-risk AI systems: High-risk AI systems require documentation to ensure that natural persons can effectively oversee their functioning.
- → biometric identification systems: Natural persons must verify and confirm the outputs of biometric identification systems to prevent incorrect actions based on their results.
- ← high-risk AI systems: The deployment of high-risk AI systems influences decisions that affect the health, safety, and rights of natural persons.
- → Regulation: Natural persons have the right to receive information and explanations regarding the use of high-risk AI systems as mandated by the Regulation.
- ← impact assessment: The impact assessment identifies specific categories of natural persons likely to be affected by the high-risk AI system.
- ← AI systems: AI systems are intended to interact with natural persons, necessitating transparency obligations.
- → vulnerable groups: Natural persons include vulnerable groups that require special consideration in AI interactions.
- ← AI system: The regulation lays down rules for the use of AI systems in making risk assessments of natural persons.
- ← biometric categorisation systems: The regulation lays down rules for the use of biometric categorisation systems that infer personal characteristics.
- → biometric data: Natural persons are the users whose biometric data is being processed under the regulation.
- ← Article 50: Article 50 lays down rules requiring that natural persons are informed when interacting with AI systems.
- ← AI systems for recruitment: These AI systems are used to recruit and select individuals for job positions.
- ← AI systems for work-related decisions: These AI systems influence work-related decisions affecting individuals.
- ← AI systems for public services evaluation: These AI systems evaluate individuals' eligibility for public assistance benefits.
- ← AI systems for creditworthiness evaluation: These AI systems assess the creditworthiness of individuals.
- ← AI systems for risk assessment in insurance: These AI systems are used for assessing risks related to individuals in insurance contexts.
- ← competent public authorities: The actions of competent public authorities in assessing natural persons can impact the market for services related to migration and asylum.
natural persons
Individuals whose rights and personal data may be affected by the deployment of high-risk AI systems.
- ← Regulation: The regulation aims to protect the fundamental rights and freedoms of natural persons located in the Union.
- ← AI systems for social scoring: AI systems for social scoring evaluate natural persons, potentially leading to discriminatory outcomes.
- ← remote biometric identification: This modality can intrusively identify natural persons, affecting their rights and freedoms.
- ← Union and national law: These laws govern the lawful evaluation practices of natural persons, ensuring their rights are protected.
- ← real-time remote biometric identification systems: The use of biometric identification systems can impact the safety and privacy of individuals.
- ← imminent threat to life: An imminent threat to life can arise from disruptions to critical infrastructure affecting individuals.
- → AI systems: Natural persons should not be judged based on AI systems' predictions without human assessment.
- → public assistance benefits: Natural persons depend on public assistance benefits and services from authorities.
- ← AI systems: AI systems determine the granting or denial of benefits to natural persons.
- ← credit score evaluation: AI systems evaluating credit scores affect natural persons' access to financial resources.
- ← AI systems: AI systems used in migration and border control management can significantly impact the treatment of vulnerable natural persons in the market.
- ← competent public authorities: Competent public authorities require documentation from natural persons applying for asylum, visa, and residence permits.
- ← High-risk AI systems: High-risk AI systems require documentation to ensure that natural persons can effectively oversee their functioning.
- → biometric identification systems: Natural persons must verify and confirm the outputs of biometric identification systems to prevent incorrect actions based on their results.
- ← high-risk AI systems: The deployment of high-risk AI systems influences decisions that affect the health, safety, and rights of natural persons.
- → Regulation: Natural persons have the right to receive information and explanations regarding the use of high-risk AI systems as mandated by the Regulation.
- ← impact assessment: The impact assessment identifies specific categories of natural persons likely to be affected by the high-risk AI system.
- ← AI systems: AI systems are intended to interact with natural persons, necessitating transparency obligations.
- → vulnerable groups: Natural persons include vulnerable groups that require special consideration in AI interactions.
- ← AI system: The regulation lays down rules for the use of AI systems in making risk assessments of natural persons.
- ← biometric categorisation systems: The regulation lays down rules for the use of biometric categorisation systems that infer personal characteristics.
- → biometric data: Natural persons are the users whose biometric data is being processed under the regulation.
- ← Article 50: Article 50 lays down rules requiring that natural persons are informed when interacting with AI systems.
- ← AI systems for recruitment: These AI systems are used to recruit and select individuals for job positions.
- ← AI systems for work-related decisions: These AI systems influence work-related decisions affecting individuals.
- ← AI systems for public services evaluation: These AI systems evaluate individuals' eligibility for public assistance benefits.
- ← AI systems for creditworthiness evaluation: These AI systems assess the creditworthiness of individuals.
- ← AI systems for risk assessment in insurance: These AI systems are used for assessing risks related to individuals in insurance contexts.
- ← competent public authorities: The actions of competent public authorities in assessing natural persons can impact the market for services related to migration and asylum.
New Legislative Framework
A framework aimed at enhancing the coherence and effectiveness of EU product legislation, ensuring compliance and safety across member states.
- → The 'Blue Guide' on the implementation of EU product rules 2022: The New Legislative Framework is clarified by the 'Blue Guide' document.
- → Union law: The New Legislative Framework clarifies that multiple acts of Union harmonization legislation may apply to a single product.
- → Union harmonised legislation: The New Legislative Framework amends and provides structure to Union harmonised legislation.
- → Regulation: The Regulation is aligned with the principles of the New Legislative Framework to ensure compliance.
- ← Regulation: The regulation may amend or interact with provisions established in the New Legislative Framework.
notification template
A standardized form that deployers must fill out to notify the market surveillance authority of their assessment results.
notified bodies
Notified bodies are organizations designated to assess the conformity of high-risk AI systems, ensuring compliance with regulatory standards through independent evaluations.
- ← conformity assessment: The conformity assessment procedure for high-risk AI systems involves notified bodies.
- ← high-risk AI systems: High-risk AI systems require third-party conformity assessments by notified bodies.
- ← national competent authorities: National competent authorities notify notified bodies under the regulation.
- ← Commission: The Commission oversees the notification process for notified bodies.
- → high-risk AI systems: Notified bodies establish rules and procedures for the conformity assessment of high-risk AI systems.
- → high-risk AI systems: Notified bodies assess and approve changes related to high-risk AI systems.
- → Regulation: Notified bodies operate in accordance with the requirements set out in the regulation.
- ← Commission: The Commission transmits identification numbers and lists to notified bodies.
- → Recommendation 2003/361/EC: Notified bodies consider the definitions in Recommendation 2003/361/EC when assessing micro- and small enterprises.
- ← Article 74: Article 74 specifies the role of market surveillance authorities as notified bodies.
- → Article 31: Notified bodies must comply with the requirements set out in Article 31.
- ← Article 31: Article 31 lays down requirements for the compliance of notified bodies.
- ← Article 78: Article 78 includes safeguards for the confidentiality of information obtained by notified bodies.
notified body
A notified body is an organization designated to assess the conformity of high-risk AI systems and issue necessary certificates.
- ← high-risk AI systems: Providers must inform the notified body that issued a certificate for the high-risk AI system.
- ← Member States: Member States require notified bodies to provide documentary evidence and accreditation certificates.
- → high-risk AI system: Notified bodies are responsible for performing conformity assessments related to high-risk AI systems.
- ← Article 31: Article 31 lays down the requirements for the establishment and operation of notified bodies.
- ← Article 29(2): Article 29(2) specifies the accreditation certificate required for notified bodies.
- ← Article 29(3): Article 29(3) specifies the documentary evidence required for notified bodies.
- → notifying authority: The notified body must inform the notifying authority about its decision to cease conformity assessment activities.
- ← notifying authority: The notifying authority investigates and raises objections regarding the notified body's compliance with requirements.
- ← Articles 29 and 30: These articles establish the procedures that the notified body must follow for notification changes.
- → high-risk AI systems: The notified body assesses high-risk AI systems and issues certificates based on compliance.
- ← notifying authority: The notifying authority informs the notified body about objections raised regarding compliance.
- → providers concerned: The notified body must inform providers about the status of their designation.
- ← Article 37: Article 37 outlines the process for challenging the competence of notified bodies.
- ← Article 31: Article 31 lays down the requirements that notified bodies must fulfill.
- ← Commission: The Commission ensures that notified bodies meet the requirements for their notification.
- ← notifying authority: The notifying authority ensures that notified bodies participate in sectoral groups.
- → sectoral group of notified bodies: Notified bodies are required to participate in the sectoral group to ensure best practices.
- ← provider: The provider must inform the notified body of any intended changes to the AI systems and involve them in the conformity assessment process.
- → AI systems: Notified bodies assess and certify AI systems based on conformity assessment procedures.
- → Article 45: Article 45 outlines the information obligations that notified bodies must follow.
- → Annex VII: Notified bodies must issue technical documentation assessment certificates and quality management system approvals as per Annex VII.
- → market surveillance authorities: Notified bodies must inform market surveillance authorities about conformity assessment activities.
- → Union technical documentation assessment certificates: Notified bodies issue and manage Union technical documentation assessment certificates.
- → quality management system approvals: Notified bodies issue quality management system approvals based on compliance with standards.
- → quality management system: The notified body assesses the quality management system for compliance with Article 17 requirements.
- → technical documentation: The notified body examines the technical documentation of the AI system.
- → training data sets: The notified body is granted access to the training data sets for conformity assessment.
- → validation data sets: The notified body is granted access to the validation data sets for conformity assessment.
- → testing data sets: The notified body is granted access to the testing data sets for conformity assessment.
- → AI system: The notified body assesses the conformity of the AI system with the requirements set out in Chapter III, Section 2.
- → Union technical documentation assessment certificate: The notified body issues a Union technical documentation assessment certificate if the AI system meets conformity requirements.
- → Chapter III, Section 2: The notified body assesses the AI system based on the requirements set out in Chapter III, Section 2.
- → quality management system: The notified body conducts surveillance to ensure compliance with the quality management system.
- → AI systems: The notified body assesses the AI systems during audits and compliance checks.
- → audit report: The notified body provides an audit report to the provider after conducting audits.
- ← Union technical documentation assessment certificate: The notified body issues the Union technical documentation assessment certificate.
- → AI system: The notified body issues certificates for AI systems, ensuring compliance with regulations.
Notifying Authorities
Organizations responsible for overseeing the notification of conformity assessment bodies and ensuring compliance with relevant regulations.
- → Conformity Assessment Bodies: Notifying authorities establish the rules and procedures for the notification of conformity assessment bodies.
- → Article 78: Notifying authorities are required to maintain confidentiality as outlined in Article 78.
notifying authority
The authority responsible for overseeing notified bodies, ensuring compliance with regulations, and confirming the status of certificates.
- ← notified body: The notified body must inform the notifying authority about its decision to cease conformity assessment activities.
- → notified body: The notifying authority investigates and raises objections regarding the notified body's compliance with requirements.
- → notified body: The notifying authority informs the notified body about objections raised regarding compliance.
- → Commission: The notifying authority informs the Commission about the status of the notified body.
- → Member States: The notifying authority informs other Member States about the suspension or withdrawal of designations.
- → high-risk AI systems: The notifying authority requires documentation to ensure the conformity of high-risk AI systems.
- → certificates: The notifying authority requires the suspension or withdrawal of unduly issued certificates.
- → national competent authorities: The notifying authority provides relevant information about certificates to national competent authorities.
- → certificates: The notifying authority confirms the status of certificates affected by suspension or restriction.
- ← certificates: Certificates require documentation and confirmation from the notifying authority regarding their status.
- ← Commission: The Commission requests relevant information from the notifying authority.
- → notified body: The notifying authority ensures that notified bodies participate in sectoral groups.
obligations
Requirements that providers of general-purpose AI models must adhere to in order to ensure safety and compliance.
Official Journal of the European Union
The Official Journal of the European Union serves as the primary publication for legal acts, regulations, and harmonised standards relevant to EU legislation.
- ← Regulation: The Regulation is published in the Official Journal of the European Union.
- ← Regulation 2024/1689: Regulation 2024/1689 includes references to harmonised standards published in the Official Journal of the European Union.
- → Article 40: The Official Journal transmits references of harmonised standards as stated in Article 40.
- ← European standardisation organisations: European standardisation organisations transmit references to harmonised standards to the Official Journal of the European Union.
- ← Regulation (EU) No 1025/2012: Regulation (EU) No 1025/2012 outlines the obligations that are published in the Official Journal.
- ← harmonised standard: A harmonised standard is proposed to the Commission for publication in the Official Journal.
- ← Commission: The Commission's decisions take effect upon publication in the Official Journal.
- → harmonised standards: The Official Journal publishes harmonised standards that may be applied to AI systems.
Official Journal of the European Union
The official publication of the European Union containing legal texts, regulations, and directives.
- ← Regulation: The Regulation is published in the Official Journal of the European Union.
- ← Regulation 2024/1689: Regulation 2024/1689 includes references to harmonised standards published in the Official Journal of the European Union.
- → Article 40: The Official Journal transmits references of harmonised standards as stated in Article 40.
- ← European standardisation organisations: European standardisation organisations transmit references to harmonised standards to the Official Journal of the European Union.
- ← Regulation (EU) No 1025/2012: Regulation (EU) No 1025/2012 outlines the obligations that are published in the Official Journal.
- ← harmonised standard: A harmonised standard is proposed to the Commission for publication in the Official Journal.
- ← Commission: The Commission's decisions take effect upon publication in the Official Journal.
- → harmonised standards: The Official Journal publishes harmonised standards that may be applied to AI systems.
OJ L
The Official Journal of the European Union, where legal documents and regulations are published, including the regulation dated 12.7.2024.
- ← Regulation (EU) 2022/2065: Regulation (EU) 2022/2065 was published in the Official Journal on 27.10.2022.
- ← AI Regulation: The regulation is published in the Official Journal of the European Union on the specified date.
- → Regulation: The Regulation is published in the Official Journal of the European Union on the date 12.7.
- → Regulation 2024/1689: The regulation is published in the Official Journal of the European Union on the specified date.
- → 12.7.2024: The regulation was published in the Official Journal on 12.7.2024.
- ← Regulation: The Regulation is published in the Official Journal of the European Union on 12.7.2024.
- → ELI: The date of publication in the Official Journal of the European Union is linked to the European Legislation Identifier.
- ← regulation 2024/1689: The regulation is published in the Official Journal of the European Union.
- ← 12.7.2024: The date 12.7.2024 is associated with the publication in the Official Journal.
- ← AI system: The AI system must disclose its nature when generating or manipulating content published in the Official Journal.
- → 12.7: The date 12.7 is associated with the publication of the regulation in the Official Journal.
- ← regulation 2024/1689: The regulation is published in the Official Journal of the European Union.
OJ L
The Official Journal of the European Union publishes legal documents, regulations, and directives.
- ← Regulation (EU) 2022/2065: Regulation (EU) 2022/2065 was published in the Official Journal on 27.10.2022.
- ← AI Regulation: The regulation is published in the Official Journal of the European Union on the specified date.
- → Regulation: The Regulation is published in the Official Journal of the European Union on the date 12.7.
- → Regulation 2024/1689: The regulation is published in the Official Journal of the European Union on the specified date.
- → 12.7.2024: The regulation was published in the Official Journal on 12.7.2024.
- ← Regulation: The Regulation is published in the Official Journal of the European Union on 12.7.2024.
- → ELI: The date of publication in the Official Journal of the European Union is linked to the European Legislation Identifier.
- ← regulation 2024/1689: The regulation is published in the Official Journal of the European Union.
- ← 12.7.2024: The date 12.7.2024 is associated with the publication in the Official Journal.
- ← AI system: The AI system must disclose its nature when generating or manipulating content published in the Official Journal.
- → 12.7: The date 12.7 is associated with the publication of the regulation in the Official Journal.
- ← regulation 2024/1689: The regulation is published in the Official Journal of the European Union.
OJ L
The Official Journal of the European Union where regulations and legal documents are published.
- ← Regulation (EU) 2022/2065: Regulation (EU) 2022/2065 was published in the Official Journal on 27.10.2022.
- ← AI Regulation: The regulation is published in the Official Journal of the European Union on the specified date.
- → Regulation: The Regulation is published in the Official Journal of the European Union on the date 12.7.
- → Regulation 2024/1689: The regulation is published in the Official Journal of the European Union on the specified date.
- → 12.7.2024: The regulation was published in the Official Journal on 12.7.2024.
- ← Regulation: The Regulation is published in the Official Journal of the European Union on 12.7.2024.
- → ELI: The date of publication in the Official Journal of the European Union is linked to the European Legislation Identifier.
- ← regulation 2024/1689: The regulation is published in the Official Journal of the European Union.
- ← 12.7.2024: The date 12.7.2024 is associated with the publication in the Official Journal.
- ← AI system: The AI system must disclose its nature when generating or manipulating content published in the Official Journal.
- → 12.7: The date 12.7 is associated with the publication of the regulation in the Official Journal.
- ← regulation 2024/1689: The regulation is published in the Official Journal of the European Union.
OJ L
The Official Journal of the European Union publishes legal documents, including regulations.
- ← Regulation (EU) 2022/2065: Regulation (EU) 2022/2065 was published in the Official Journal on 27.10.2022.
- ← AI Regulation: The regulation is published in the Official Journal of the European Union on the specified date.
- → Regulation: The Regulation is published in the Official Journal of the European Union on the date 12.7.
- → Regulation 2024/1689: The regulation is published in the Official Journal of the European Union on the specified date.
- → 12.7.2024: The regulation was published in the Official Journal on 12.7.2024.
- ← Regulation: The Regulation is published in the Official Journal of the European Union on 12.7.2024.
- → ELI: The date of publication in the Official Journal of the European Union is linked to the European Legislation Identifier.
- ← regulation 2024/1689: The regulation is published in the Official Journal of the European Union.
- ← 12.7.2024: The date 12.7.2024 is associated with the publication in the Official Journal.
- ← AI system: The AI system must disclose its nature when generating or manipulating content published in the Official Journal.
- → 12.7: The date 12.7 is associated with the publication of the regulation in the Official Journal.
- ← regulation 2024/1689: The regulation is published in the Official Journal of the European Union.
OJ L
Official Journal of the European Union where regulations and directives are published.
- ← Regulation (EU) 2022/2065: Regulation (EU) 2022/2065 was published in the Official Journal on 27.10.2022.
- ← AI Regulation: The regulation is published in the Official Journal of the European Union on the specified date.
- → Regulation: The Regulation is published in the Official Journal of the European Union on the date 12.7.
- → Regulation 2024/1689: The regulation is published in the Official Journal of the European Union on the specified date.
- → 12.7.2024: The regulation was published in the Official Journal on 12.7.2024.
- ← Regulation: The Regulation is published in the Official Journal of the European Union on 12.7.2024.
- → ELI: The date of publication in the Official Journal of the European Union is linked to the European Legislation Identifier.
- ← regulation 2024/1689: The regulation is published in the Official Journal of the European Union.
- ← 12.7.2024: The date 12.7.2024 is associated with the publication in the Official Journal.
- ← AI system: The AI system must disclose its nature when generating or manipulating content published in the Official Journal.
- → 12.7: The date 12.7 is associated with the publication of the regulation in the Official Journal.
- ← regulation 2024/1689: The regulation is published in the Official Journal of the European Union.
OJ L
Official Journal of the European Union where the regulation is published.
- ← Regulation (EU) 2022/2065: Regulation (EU) 2022/2065 was published in the Official Journal on 27.10.2022.
- ← AI Regulation: The regulation is published in the Official Journal of the European Union on the specified date.
- → Regulation: The Regulation is published in the Official Journal of the European Union on the date 12.7.
- → Regulation 2024/1689: The regulation is published in the Official Journal of the European Union on the specified date.
- → 12.7.2024: The regulation was published in the Official Journal on 12.7.2024.
- ← Regulation: The Regulation is published in the Official Journal of the European Union on 12.7.2024.
- → ELI: The date of publication in the Official Journal of the European Union is linked to the European Legislation Identifier.
- ← regulation 2024/1689: The regulation is published in the Official Journal of the European Union.
- ← 12.7.2024: The date 12.7.2024 is associated with the publication in the Official Journal.
- ← AI system: The AI system must disclose its nature when generating or manipulating content published in the Official Journal.
- → 12.7: The date 12.7 is associated with the publication of the regulation in the Official Journal.
- ← regulation 2024/1689: The regulation is published in the Official Journal of the European Union.
OJ L 117, 5.5.2017
The official journal publication date for Regulation (EU) 2017/746.
OJ L 135, 22.5.2019
The official journal publication date for Regulation (EU) 2019/816.
OJ L 236, 19.9.2018
The official journal publication date for Regulation (EU) 2018/1241.
OJ L 60, 2.3.2013
The official journal publication date for both Regulation (EU) No 168/2013 and Regulation (EU) No 167/2013.
OJ L 80, 23.3.2002
The official journal date for Directive 2002/14/EC.
OJ L 97, 9.4.2008
The official journal publication date for Regulation (EC) No 300/2008.
OJ L, 12.7.2024
This date refers to the official journal publication of the regulation, marking its formal release and entry into effect.
- ← Regulation 2024/1689: Regulation 2024/1689 was published in the official journal on July 12, 2024.
- → AI systems for remote biometric identification: The regulation concerning AI systems for biometric identification was published on this date.
- → high-risk AI systems: The regulation concerning high-risk AI systems was published in the official journal on 12.7.2024.
- ← Regulation (EU) No 1025/2012: The regulation is published in the Official Journal on this date.
- → Regulation 2024/1689: Regulation 2024/1689 was published in the official journal on 12.7.2024.
- → AI Office: The regulation published in the Official Journal on this date includes provisions related to the AI Office.
- → Regulation: The regulation was published in the official journal on this date.
- → 12.7.2024: The official journal entry is dated 12.7.2024.
- → high-risk AI system: The regulation concerning high-risk AI systems was published on this date.
- → high-risk AI systems: The publication date indicates when the regulation concerning high-risk AI systems was officially released.
- ← Article 15: Article 15 is published in the official journal on this date.
- → Article 52: The date indicates when Article 52 was published in the official journal.
- → Article 73: The date indicates when the regulation including Article 73 was published.
- → Directive (EU) 2016/680: The publication date of the official journal where the directive is recorded.
- → Article 49: The date when Article 49 was published in the official journal.
- → Regulation (EU) 2016/679: The publication date indicates the regulation's amendments or updates related to AI systems.
- → Regulation (EU) 2016/679: The date of publication in the Official Journal for Regulation (EU) 2016/679.
- → Regulation (EU) 2019/817: A future publication date referenced in the context of Regulation (EU) 2019/817.
- ← reg/2024/1689/oj: The regulation has a publication date in the official journal.
OJ L, 12.7.2024
This entry in the Official Journal references the regulation regarding high-risk AI systems adopted on July 12, 2024.
- ← Regulation 2024/1689: Regulation 2024/1689 was published in the official journal on July 12, 2024.
- → AI systems for remote biometric identification: The regulation concerning AI systems for biometric identification was published on this date.
- → high-risk AI systems: The regulation concerning high-risk AI systems was published in the official journal on 12.7.2024.
- ← Regulation (EU) No 1025/2012: The regulation is published in the Official Journal on this date.
- → Regulation 2024/1689: Regulation 2024/1689 was published in the official journal on 12.7.2024.
- → AI Office: The regulation published in the Official Journal on this date includes provisions related to the AI Office.
- → Regulation: The regulation was published in the official journal on this date.
- → 12.7.2024: The official journal entry is dated 12.7.2024.
- → high-risk AI system: The regulation concerning high-risk AI systems was published on this date.
- → high-risk AI systems: The publication date indicates when the regulation concerning high-risk AI systems was officially released.
- ← Article 15: Article 15 is published in the official journal on this date.
- → Article 52: The date indicates when Article 52 was published in the official journal.
- → Article 73: The date indicates when the regulation including Article 73 was published.
- → Directive (EU) 2016/680: The publication date of the official journal where the directive is recorded.
- → Article 49: The date when Article 49 was published in the official journal.
- → Regulation (EU) 2016/679: The publication date indicates the regulation's amendments or updates related to AI systems.
- → Regulation (EU) 2016/679: The date of publication in the Official Journal for Regulation (EU) 2016/679.
- → Regulation (EU) 2019/817: A future publication date referenced in the context of Regulation (EU) 2019/817.
- ← reg/2024/1689/oj: The regulation has a publication date in the official journal.
OJ L, 12.7.2024
Official Journal of the European Union where the regulation is published.
- ← Regulation 2024/1689: Regulation 2024/1689 was published in the official journal on July 12, 2024.
- → AI systems for remote biometric identification: The regulation concerning AI systems for biometric identification was published on this date.
- → high-risk AI systems: The regulation concerning high-risk AI systems was published in the official journal on 12.7.2024.
- ← Regulation (EU) No 1025/2012: The regulation is published in the Official Journal on this date.
- → Regulation 2024/1689: Regulation 2024/1689 was published in the official journal on 12.7.2024.
- → AI Office: The regulation published in the Official Journal on this date includes provisions related to the AI Office.
- → Regulation: The regulation was published in the official journal on this date.
- → 12.7.2024: The official journal entry is dated 12.7.2024.
- → high-risk AI system: The regulation concerning high-risk AI systems was published on this date.
- → high-risk AI systems: The publication date indicates when the regulation concerning high-risk AI systems was officially released.
- ← Article 15: Article 15 is published in the official journal on this date.
- → Article 52: The date indicates when Article 52 was published in the official journal.
- → Article 73: The date indicates when the regulation including Article 73 was published.
- → Directive (EU) 2016/680: The publication date of the official journal where the directive is recorded.
- → Article 49: The date when Article 49 was published in the official journal.
- → Regulation (EU) 2016/679: The publication date indicates the regulation's amendments or updates related to AI systems.
- → Regulation (EU) 2016/679: The date of publication in the Official Journal for Regulation (EU) 2016/679.
- → Regulation (EU) 2019/817: A future publication date referenced in the context of Regulation (EU) 2019/817.
- ← reg/2024/1689/oj: The regulation has a publication date in the official journal.
online marketplaces
Platforms where products are sold, allowing consumers to preview items using filters.
online social network services
Platforms that allow users to share content online, which may include features for modifying pictures or videos.
open-source license
A type of software license that allows users to freely use, modify, and distribute the software.
- ← general-purpose AI models: General-purpose AI models released under an open-source license must have their parameters publicly available.
open-source model
A general-purpose AI model that is released to the public with its source code available for use and modification.
- → Regulation 2024/1689: The release of open-source models may complicate compliance with the obligations under Regulation 2024/1689.
operator
An entity involved in the operation of an AI system, which may include providers, manufacturers, and distributors, and can be held liable for infringements.
- → AI system: The operator encompasses various roles involved in the handling of AI systems.
- ← administrative fine: Administrative fines are imposed on operators for infringements, affecting their market operations.
- → national competent authorities: Operators must cooperate with national competent authorities to remedy infringements.
- ← market surveillance authorities: Market surveillance authorities may apply administrative fines to operators for infringements.
- → Union or national law: Operators must comply with Union or national law to avoid infringements and fines.
paragraph 1, first subparagraph, point (h)
A provision outlining objectives related to the use of biometric identification systems.
paragraph 5
A provision that allows Member States to authorize the use of biometric identification systems under certain conditions.
parameters
Quantitative measures that define the characteristics and capabilities of AI models, influencing their generality and performance. Relevant parameters of the AI system that may be assessed by the notified body. The architecture and number of parameters that define the structure and functionality of the AI model. Quantitative measures that define the characteristics of an AI model.
- ← models: Models can be characterized by a number of parameters, which influence their generality and performance.
- ← AI system: The AI system has relevant parameters that may be assessed by the notified body.
- ← general-purpose AI model: The general-purpose AI model includes specific parameters that define its architecture.
personal data
Personal data refers to any information relating to an identified or identifiable individual, which is protected under EU law and must be processed in compliance with data protection regulations.
- ← 2024/1689: The regulation contains specific rules on the protection of personal data in relation to AI systems.
- ← Regulation (EC) No 765/2008: The regulation outlines requirements that affect the processing of personal data.
- ← Decision No 768/2008/EC: The decision provides a framework that includes considerations for the marketing of products involving personal data.
- ← AI systems: AI systems must comply with documentation requirements related to the processing of personal data.
- ← Article 16 TFEU: Article 16 TFEU lays down rules for the processing of personal data by Member States.
- ← AI systems: The classification of AI systems as high-risk does not imply lawful use under personal data protection laws.
- ← Regulation: The Regulation specifies that processing of personal data must comply with applicable legal grounds, including those outlined in the Regulation itself.
- ← Regulation (EU) 2016/679: The regulation establishes rules for the handling and protection of personal data.
- ← Union data protection law: This law applies principles of data protection to the processing of personal data.
- ← AI system: AI systems must process personal data in compliance with data protection principles.
- ← Regulation (EU) 2016/679: This regulation includes safeguards for the processing of personal data.
- ← Regulation (EU) 2018/1725: This regulation provides safeguards for the processing of personal data by EU institutions.
- ← Directive (EU) 2016/680: This directive includes provisions for the protection of personal data in criminal justice contexts.
- → Free and open-source AI components: The use of personal data in relation to free and open-source AI components must be documented and limited.
- ← general-purpose AI models: General-purpose AI models may utilize personal data for various purposes, including training and fine-tuning.
- → microenterprises: Transactions between microenterprises are exempt from certain regulations regarding the use of personal data.
- ← AI regulatory sandbox: The AI regulatory sandbox allows the use of personal data for developing AI systems under specified conditions.
- ← AI system: The AI system must include safeguards to protect personal data and ensure it is deleted when consent is withdrawn.
- ← Regulation (EU) 2022/868: This regulation lays down rules for the protection of personal data under Union law.
- ← Regulation (EU) 2023/2854: This regulation establishes rules for the transfer of personal data under Union law.
- ← market surveillance authority: Market surveillance authorities have the power to access personal data necessary for their investigative tasks.
- ← Regulation (EU) 2016/679: This regulation affects the processing of personal data in relation to AI systems.
- ← Regulation (EU) 2018/1725: This regulation affects the processing of personal data by EU institutions.
- ← Directive 2002/58/EC: This directive impacts the privacy of personal data in electronic communications.
- ← Regulation (EU) 2016/680: This regulation governs the processing of personal data in police and judicial contexts.
- ← serious incident: Serious incidents can lead to infringements of obligations under Union law protecting personal data.
- → training data sets: Training data sets that include personal data must have safeguards in place to protect individuals' rights and privacy.
- ← high-risk AI system: The high-risk AI system requires documentation on the processing of personal data to ensure compliance with regulations.
- → Regulation (EU) 2016/679: The processing of personal data must comply with Regulation (EU) 2016/679.
- → Regulation (EU) 2018/1725: The processing of personal data must comply with Regulation (EU) 2018/1725.
- → Directive (EU) 2016/680: The processing of personal data must comply with Directive (EU) 2016/680.
- ← Regulations (EU) 2016/679: Sets rules for the processing of personal data to ensure protection and security.
- ← Regulations (EU) 2018/1725: Establishes rules for the processing of personal data by EU institutions.
- ← Directive (EU) 2016/680: Provides guidelines for the processing of personal data for law enforcement purposes.
- ← high-risk AI systems: High-risk AI systems must comply with laws protecting personal data.
- ← high-risk AI systems: High-risk AI systems must comply with regulations regarding the protection of personal data.
- ← emotion recognition system: Deployers must inform individuals about the operation of the emotion recognition system and how personal data is processed.
- ← biometric categorisation system: Deployers must inform individuals about the operation of the biometric categorisation system and how personal data is processed.
- ← deep fake: Deployers must disclose when content has been artificially generated or manipulated.
- ← national competent authorities: National competent authorities ensure compliance with regulations regarding the processing of personal data in AI systems.
- ← AI regulatory sandbox: The AI regulatory sandbox requires documentation on the lawful collection and processing of personal data for AI system development.
- ← sandbox: The sandbox requires documentation to ensure that personal data is processed in a secure and compliant manner.
- ← Union law on the protection of personal data: Union law establishes rules for the protection and processing of personal data.
- ← AI regulatory sandboxes: AI regulatory sandboxes establish rules for the processing of personal data under specific conditions.
- ← Union law: Union law includes safeguards for the processing of personal data, ensuring compliance with data protection standards.
- ← AI system: The AI system must ensure the deletion of personal data after testing.
- ← EU database: The EU database contains personal data necessary for compliance with regulations.
persons living in extreme poverty
Individuals who are particularly vulnerable to exploitation by manipulative AI systems due to their socio-economic situation.
polygraphs
Tools used to evaluate the reliability of evidence in investigations or prosecutions.
post-market monitoring plan
The post-market monitoring plan is a documented strategy that providers must establish to monitor the performance of high-risk AI systems.
- ← high-risk AI systems: High-risk AI systems require a documented post-market monitoring plan to evaluate their compliance.
- → Annex IV: The post-market monitoring plan is part of the technical documentation outlined in Annex IV.
- → Union harmonisation legislation: The post-market monitoring plan is developed in accordance with the Union harmonisation legislation.
post-market monitoring plan
A plan that outlines the necessary elements to be included for monitoring high-risk AI systems after they have been placed on the market.
- ← high-risk AI systems: High-risk AI systems require a documented post-market monitoring plan to evaluate their compliance.
- → Annex IV: The post-market monitoring plan is part of the technical documentation outlined in Annex IV.
- → Union harmonisation legislation: The post-market monitoring plan is developed in accordance with the Union harmonisation legislation.
post-market monitoring system
A system that high-risk AI system providers must implement to monitor performance and risks after market release.
- ← high-risk AI systems: High-risk AI systems require a post-market monitoring system to ensure ongoing safety and compliance.
- → AI system: The post-market monitoring system requires documentation of user experience for corrective actions.
- ← risk management system: The risk management system utilizes data from the post-market monitoring system to evaluate risks.
post-market monitoring system
Activities by AI system providers to collect and review user experience for corrective or preventive actions.
- ← high-risk AI systems: High-risk AI systems require a post-market monitoring system to ensure ongoing safety and compliance.
- → AI system: The post-market monitoring system requires documentation of user experience for corrective actions.
- ← risk management system: The risk management system utilizes data from the post-market monitoring system to evaluate risks.
post-remote biometric identification system
A remote biometric identification system that does not operate in real-time.
- → biometric data: The post-remote biometric identification system uses biometric data for identification, but not in real-time.
post-remote biometric identification systems
AI systems used for biometric identification that operate after the event, requiring strict safeguards due to their intrusive nature.
- → Article 10 of Directive (EU) 2016/680: The use of post-remote biometric identification systems must comply with the stipulations of Article 10 regarding the processing of biometric data.
- → Regulation (EU) 2016/679: The use of post-remote biometric identification systems is subject to the provisions of Regulation (EU) 2016/679.
- → Directive (EU) 2016/680: The use of post-remote biometric identification systems must adhere to the principles outlined in Directive (EU) 2016/680.
pre-training
An activity intended to enhance the capabilities of a general-purpose AI model prior to its deployment.
- ← general-purpose AI model: Pre-training is a necessary step in the development of general-purpose AI models to enhance their capabilities.
presumption of innocence
The legal principle that one is considered innocent until proven guilty, which could be undermined by AI system decisions.
- ← AI systems: AI systems could undermine the presumption of innocence in legal proceedings.
product manufacturer
An entity responsible for producing goods that may incorporate high-risk AI systems and ensuring regulatory compliance.
- → Regulation: The product manufacturer must comply with the obligations set out in the Regulation.
- → high-risk AI systems: The product manufacturer is responsible for ensuring that high-risk AI systems comply with the obligations set out in the regulation.
professional pilots
Individuals whose fatigue states may be monitored to prevent accidents, not included in the emotion recognition system.
Prohibited AI practices
A set of practices involving AI systems that are deemed unacceptable due to their potential to cause significant harm to individuals or groups.
- → AI systems: Defines the rules and restrictions regarding the use of AI systems that could cause harm.
- ← Article 5: Article 5 specifically addresses the prohibited practices related to AI systems.
prohibited systems
AI systems that are banned from being placed on the market due to regulatory violations.
Protocol No 21
A protocol concerning the position of the United Kingdom and Ireland in respect of the area of freedom, security, and justice.
- → Article 5(1): Protocol No 21 states that Ireland is not bound by certain rules laid down in Article 5(1) regarding biometric systems.
Protocol No 22
Protocol No 22 addresses the position of Denmark in relation to EU law, particularly concerning judicial cooperation.
- → TEU: Protocol No 22 is annexed to the TEU, outlining Denmark's position regarding EU regulations.
provider
The entity responsible for the development, deployment, and oversight of high-risk AI systems, including risk identification and mitigation measures.
- → risk-management system: The provider must document and explain the choices made in the risk-management system.
- → high-risk AI systems: Providers must ensure that high-risk AI systems are managed in accordance with regulations and designed with oversight measures before market placement.
- ← AI system: The provider develops or places the AI system on the market.
- → authorised representative: The provider mandates the authorised representative to perform obligations on its behalf.
- → Article 49(2): Providers of AI systems must document their assessment of risk before placing the system on the market as stipulated in Article 49(2).
- → high-risk AI system: The provider must ensure that the high-risk AI system complies with the regulation.
- ← deployer: The deployer informs the provider about risks associated with the high-risk AI system.
- → high-risk AI system: The provider supplies the high-risk AI system to the deployer.
- → notified body: The provider must inform the notified body of any intended changes to the AI systems and involve them in the conformity assessment process.
- → EU database: Providers must register themselves and their high-risk AI systems in the EU database.
- ← Article 6(3): Article 6(3) lays down rules for determining if a provider's AI system is high-risk.
- → serious incident: The provider is required to report serious incidents related to AI systems.
- → competent authorities: The provider must cooperate with competent authorities during investigations of serious incidents.
- → high-risk AI system: The provider must perform necessary investigations related to the high-risk AI system involved in the serious incident.
- → risk assessment: The investigation performed by the provider includes a risk assessment of the serious incident.
- → AI system: The provider must ensure that the AI system complies with the requirements laid down in the regulation.
- → Article 99: If the provider fails to comply with the requirements, they are subject to fines as specified in Article 99.
- → technical documentation: The provider must submit technical documentation for assessment by the notified body.
- → quality management system: The provider is required to maintain and apply the quality management system.
provider
An entity, either natural or legal, responsible for developing, placing, and ensuring compliance of high-risk AI systems in the market.
- → risk-management system: The provider must document and explain the choices made in the risk-management system.
- → high-risk AI systems: Providers must ensure that high-risk AI systems are managed in accordance with regulations and designed with oversight measures before market placement.
- ← AI system: The provider develops or places the AI system on the market.
- → authorised representative: The provider mandates the authorised representative to perform obligations on its behalf.
- → Article 49(2): Providers of AI systems must document their assessment of risk before placing the system on the market as stipulated in Article 49(2).
- → high-risk AI system: The provider must ensure that the high-risk AI system complies with the regulation.
- ← deployer: The deployer informs the provider about risks associated with the high-risk AI system.
- → high-risk AI system: The provider supplies the high-risk AI system to the deployer.
- → notified body: The provider must inform the notified body of any intended changes to the AI systems and involve them in the conformity assessment process.
- → EU database: Providers must register themselves and their high-risk AI systems in the EU database.
- ← Article 6(3): Article 6(3) lays down rules for determining if a provider's AI system is high-risk.
- → serious incident: The provider is required to report serious incidents related to AI systems.
- → competent authorities: The provider must cooperate with competent authorities during investigations of serious incidents.
- → high-risk AI system: The provider must perform necessary investigations related to the high-risk AI system involved in the serious incident.
- → risk assessment: The investigation performed by the provider includes a risk assessment of the serious incident.
- → AI system: The provider must ensure that the AI system complies with the requirements laid down in the regulation.
- → Article 99: If the provider fails to comply with the requirements, they are subject to fines as specified in Article 99.
- → technical documentation: The provider must submit technical documentation for assessment by the notified body.
- → quality management system: The provider is required to maintain and apply the quality management system.
providers
Entities that enter data into the EU database and may include individuals or organizations.
- → Commission: Providers may request the Commission to reassess the designation of their AI model after a specified period.
- → EU database: Providers enter data into the EU database as required by the regulation.
public assistance benefits
Essential benefits and services provided by public authorities, including healthcare, social security, and housing assistance.
- ← natural persons: Natural persons depend on public assistance benefits and services from authorities.
public authorities
Government entities that may deploy high-risk AI systems and are responsible for implementing regulations at national or regional levels.
- → Regulation: Public authorities of third countries may be exempt from the regulation under specific cooperation agreements.
- → EU database: Public authorities deploying high-risk AI systems must register in the EU database.
public interest
The societal concern that justifies the disclosure of AI-generated content to inform the public.
- ← Regulation (EU) 2022/2065: The regulation aims to improve public interest by ensuring transparency in AI-generated content.
public security
The use of AI systems to ensure the safety and security of the public.
- ← AI systems: AI systems can be utilized to enhance public security.
publicly accessible space
A physical space accessible to an undetermined number of natural persons, regardless of ownership or activity type.
- ← Regulation 2024/1689: Regulation 2024/1689 defines the rules and characteristics of publicly accessible spaces.
publicly accessible space
Any physical location that is accessible to an undetermined number of individuals, regardless of access conditions.
- ← Regulation 2024/1689: Regulation 2024/1689 defines the rules and characteristics of publicly accessible spaces.
quality data
Data used to train the AI system, which must meet certain quality standards for compliance.
- ← AI system: The AI system requires quality data for training to ensure compliance.
quality management system
A structured system ensuring the quality of AI products and services, particularly in compliance with regulatory standards.
- → high-risk AI system: The quality management system should be integrated into the design of the high-risk AI system.
- → AI system: The quality management system lays down rules for the design, development, and testing of AI systems.
- ← notified body: The notified body assesses the quality management system for compliance with Article 17 requirements.
- ← Article 17: Article 17 outlines the requirements for the quality management system.
- ← notified body: The notified body conducts surveillance to ensure compliance with the quality management system.
- ← provider: The provider is required to maintain and apply the quality management system.
quality management system
A system ensuring quality in processes and products, which microenterprises are encouraged to establish in a simplified manner, particularly for high-risk AI systems.
- → high-risk AI system: The quality management system should be integrated into the design of the high-risk AI system.
- → AI system: The quality management system lays down rules for the design, development, and testing of AI systems.
- ← notified body: The notified body assesses the quality management system for compliance with Article 17 requirements.
- ← Article 17: Article 17 outlines the requirements for the quality management system.
- ← notified body: The notified body conducts surveillance to ensure compliance with the quality management system.
- ← provider: The provider is required to maintain and apply the quality management system.
quality management system
A system implemented by the provider to ensure that AI systems are adequately managed and maintained.
- → high-risk AI system: The quality management system should be integrated into the design of the high-risk AI system.
- → AI system: The quality management system lays down rules for the design, development, and testing of AI systems.
- ← notified body: The notified body assesses the quality management system for compliance with Article 17 requirements.
- ← Article 17: Article 17 outlines the requirements for the quality management system.
- ← notified body: The notified body conducts surveillance to ensure compliance with the quality management system.
- ← provider: The provider is required to maintain and apply the quality management system.
quality management system
A structured system that ensures the quality of processes and products, which the provider must comply with.
- → high-risk AI system: The quality management system should be integrated into the design of the high-risk AI system.
- → AI system: The quality management system lays down rules for the design, development, and testing of AI systems.
- ← notified body: The notified body assesses the quality management system for compliance with Article 17 requirements.
- ← Article 17: Article 17 outlines the requirements for the quality management system.
- ← notified body: The notified body conducts surveillance to ensure compliance with the quality management system.
- ← provider: The provider is required to maintain and apply the quality management system.
quality management system approvals
Approvals granted to organizations indicating that their quality management systems comply with specified standards.
- ← notified body: Notified bodies issue quality management system approvals based on compliance with standards.
R. Metsola
The President of the European Parliament who signed the regulation.
Real-time Biometric Identification System
An AI system used for the real-time identification of individuals based on biometric data.
- → Biometric Data: The Real-time Biometric Identification System processes Biometric Data for identification purposes.
real-time biometric identification systems
Systems that use biometric data for identification in real-time, requiring authorization for their use.
real-time remote biometric identification system
This AI system identifies individuals in real-time using biometric data in publicly accessible spaces, primarily for law enforcement applications.
- ← law enforcement authority: The law enforcement authority must authorize the use of the biometric identification system.
- → fundamental rights impact assessment: The use of the biometric identification system requires a fundamental rights impact assessment to be completed.
- ← reference database of persons: The reference database should be appropriate for the use cases of the biometric identification system.
- ← urgent situations: In urgent situations, exceptions to the usual authorization process for the biometric identification system are allowed.
- → biometric data: The real-time remote biometric identification system uses biometric data for immediate identification.
- → judicial authority: The use of the biometric identification system requires prior authorization from a judicial authority.
- → independent administrative authority: The use of the biometric identification system may also require authorization from an independent administrative authority.
- → EU database: The regulation lays down rules for the registration of the biometric identification system in the EU database.
- → national data protection authority: The use of the biometric identification system must be notified to the national data protection authority.
- → market surveillance authority: The use of the biometric identification system must be notified to the market surveillance authority.
- ← Member State: Member States lay down national laws governing the use of biometric identification systems.
- ← paragraph 1, first subparagraph, point (h): This provision includes safeguards regarding the use of biometric identification systems.
- ← paragraph 5: Paragraph 5 proposes conditions under which Member States may authorize the use of biometric identification systems.
real-time remote biometric identification systems
These AI systems are used for the real-time identification of individuals through biometric data, particularly in public spaces for law enforcement purposes.
- ← Council Framework Decision 2002/584/JHA: The framework decision outlines criminal offences that may necessitate the use of biometric identification systems.
- → natural persons: The use of biometric identification systems can impact the safety and privacy of individuals.
- ← law enforcement authorities: Law enforcement authorities utilize biometric identification systems to confirm identities during checks.
- → Article 9: The use of biometric identification systems must comply with the stipulations of Article 9 regarding the processing of biometric data.
- → Article 27: The use of these systems requires a fundamental rights impact assessment as mandated by Article 27.
- → Article 49: The systems must be registered in the EU database as per the requirements of Article 49.
- ← Regulation (EU) 2016/679: Regulation (EU) 2016/679 lays down rules for the processing of biometric data, which includes the use of remote identification systems.
- → law enforcement: These AI systems are used in accordance with laws governing law enforcement activities.
real-time systems
AI systems that capture, compare, and identify biometric data instantaneously or with minimal delay.
- → biometric data: Real-time systems utilize biometric data for immediate identification processes.
real-world testing plan
A detailed document outlining the objectives and methodologies for testing high-risk AI systems in real-world conditions.
- → AI regulatory sandbox: The real-world testing plan is necessary for conducting tests within the AI regulatory sandbox.
- ← high-risk AI systems: High-risk AI systems require a real-world testing plan to be developed and followed during testing.
- ← market surveillance authority: The market surveillance authority must approve the real-world testing plan before testing can commence.
- → Article 71(4): The real-world testing plan must comply with the requirements set out in Article 71(4).
- → Annex IX: The real-world testing plan must include information specified in Annex IX.
Recommendation 2003/361/EC
A recommendation defining micro- and small enterprises, providing guidelines for their compliance with quality management systems.
- ← notified bodies: Notified bodies consider the definitions in Recommendation 2003/361/EC when assessing micro- and small enterprises.
- ← Regulation 2024/1689: The regulation acts in accordance with the guidelines set forth in Recommendation 2003/361/EC regarding microenterprises.
reference database of persons
A database that contains information about individuals, which should be appropriate for each use case of biometric identification.
reg/2024/1689/oj
A specific regulation referenced in the European legal framework.
Registered business users
Businesses that have registered to use the AI models, with a threshold of at least 10,000 users for presumed high impact.
- ← Internal market: The internal market includes registered business users of AI models.
Registered end-users
Individuals who have registered to use the AI models.
Regulation
This comprehensive legal framework governs the use of AI systems within the EU, ensuring safety, fundamental rights, and non-discriminatory practices while addressing high-risk applications, market surveillance, and compliance obligations for providers and deployers.
- → Charter of Fundamental Rights of the European Union: The Regulation is applied in accordance with the values enshrined in the Charter.
- → AI systems: The Regulation establishes rules for the development, marketing, and use of AI systems to ensure safety and trustworthiness, particularly in military and national security contexts.
- → Official Journal of the European Union: The Regulation is published in the Official Journal of the European Union.
- → UNCRC General Comment No 25 (2021): The Regulation acknowledges the importance of the UNCRC General Comment in relation to the protection of minors.
- → Regulations (EU) 2016/679: The Regulation includes safeguards that align with the provisions of Regulations (EU) 2016/679.
- → Regulation (EU) 2018/1725: The Regulation incorporates safeguards consistent with Regulation (EU) 2018/1725.
- → Directive (EU) 2016/680: The Regulation aligns with the protections established by Directive (EU) 2016/680, including safeguards for biometric data processing.
- → Directive 2002/58/EC: The Regulation is designed to work in conjunction with Directive 2002/58/EC to protect personal data.
- → remote biometric identification system: The Regulation establishes rules governing the use of remote biometric identification systems.
- ← AI literacy: AI literacy aims to improve compliance and enforcement of the Regulation.
- → Union: The Regulation applies to providers and deployers of AI systems within the Union.
- → high-risk AI systems: The Regulation includes provisions for high-risk AI systems, ensuring affected persons can obtain explanations for decisions based on these systems.
- → natural persons: The regulation aims to protect the fundamental rights and freedoms of natural persons located in the Union.
- ← public authorities: Public authorities of third countries may be exempt from the regulation under specific cooperation agreements.
- ← international organisations: International organisations may also be exempt from the regulation when acting under cooperation agreements.
- ← AI system: AI systems must comply with the Regulation unless they are used for excluded purposes.
- → military purposes: The Regulation explicitly excludes military, defense, and national security uses of AI systems.
- → scientific research and development: The Regulation does not apply to AI systems developed solely for scientific research and development.
- → law enforcement authorities: The Regulation establishes guidelines for how law enforcement authorities can conduct identity checks.
- → border control authorities: The Regulation provides rules for border control authorities regarding identity verification processes.
- → immigration authorities: The Regulation outlines the procedures immigration authorities must follow during identity checks.
- → asylum authorities: The Regulation specifies how asylum authorities should conduct identity checks in compliance with the law.
- ← Member State: Member States must act in accordance with the Regulation when deciding on the use of biometric identification systems.
- → Article 16 TFEU: The Regulation amends the application of Article 16 TFEU regarding the processing of biometric data.
- → Directive (EU) 2016/680: The Regulation acts in accordance with the rules set by Directive (EU) 2016/680 regarding biometric data processing.
- → high-risk AI systems: The Regulation establishes criteria, mandatory requirements, and rules for identifying and managing high-risk AI systems to ensure trustworthiness and protect fundamental rights.
- → AI system: The Regulation includes safeguards for AI systems that do not materially influence decision-making.
- ← OJ L: The Regulation is published in the Official Journal of the European Union on the date 12.7.
- → personal data: The Regulation specifies that processing of personal data must comply with applicable legal grounds, including those outlined in the Regulation itself.
- → high-risk AI system: The regulation establishes rules for assessing and managing risks associated with high-risk AI systems.
- ← high-risk AI systems: High-risk AI systems must comply with the requirements set forth in the applicable regulations.
- → technical documentation: The Regulation requires the maintenance of technical documentation for high-risk AI systems.
- → cyber resilience: The regulation includes safeguards to ensure the cyber resilience of AI systems.
- → conformity assessment procedure: The regulation includes a conformity assessment procedure for evaluating compliance.
- ← New Legislative Framework: The Regulation is aligned with the principles of the New Legislative Framework to ensure compliance.
- ← High-risk AI system: High-risk AI systems are subject to specific documentation requirements as outlined in the regulation.
- → New Legislative Framework: The regulation may amend or interact with provisions established in the New Legislative Framework.
- ← product manufacturer: The product manufacturer must comply with the obligations set out in the Regulation.
- ← natural persons: Natural persons have the right to receive information and explanations regarding the use of high-risk AI systems as mandated by the Regulation.
- ← general-purpose AI models: The Regulation establishes obligations for the providers of general-purpose AI models once they are placed on the market.
- → models: The Regulation includes safeguards that apply to models with systemic risk, ensuring they meet relevant obligations.
- ← Commission: The Commission is empowered to amend the annexes of the Regulation.
- ← General-purpose AI models: General-purpose AI models must comply with the stipulations of the Regulation regarding transparency.
- ← Free and open-source AI components: The Regulation includes safeguards for free and open-source AI components to ensure they are not monetized improperly.
- ← general-purpose AI models: General-purpose AI models must comply with the documentation requirements set by the Regulation.
- → AI Office: The Regulation empowers the AI Office to monitor compliance and classify AI models.
- → CE marking: The Regulation requires high-risk AI systems to bear the CE marking to indicate conformity.
- → 12.7.2024: The regulation is associated with the effective date of 12.7.2024.
- → Mutual recognition agreements: The Regulation proposes the conclusion of mutual recognition agreements with third countries.
- ← high-risk AI systems: The Regulation lays down rules for the development and testing of high-risk AI systems.
- → competent authorities: The Regulation requires competent authorities to oversee the testing and development of AI systems.
- → vulnerable groups: The Regulation includes safeguards for vulnerable groups during AI system testing.
- ← AI-on-demand platform: The AI-on-demand platform contributes to the implementation of the Regulation.
- ← European Digital Innovation Hubs: The hubs provide support for the implementation of the Regulation.
- ← testing and experimentation facilities: These facilities contribute to the implementation of the Regulation.
- → governance framework: The Regulation establishes a governance framework for its application.
- ← Board: The Board is established to facilitate the implementation of the Regulation.
- → Article 30 of Regulation (EU) 2019/1020: The Regulation references Article 30 regarding the administrative cooperation group.
- → Article 33 of Regulation (EU) 2019/1020: The Regulation references Article 33 regarding the Commission's support for market surveillance.
- ← Advisory Forum: The Advisory Forum acts in accordance with the Regulation to provide technical expertise.
- ← Member States: Member States are required to apply and enforce the Regulation, including implementing rules on penalties.
- → OJ L: The Regulation is published in the Official Journal of the European Union on 12.7.2024.
- → ELI: The Regulation includes a link to the electronic legal information system for further reference.
- → Regulation (EU) 2019/1020: The Regulation amends and incorporates the provisions of Regulation (EU) 2019/1020 for market surveillance.
- ← market surveillance authorities: Market surveillance authorities act in accordance with the provisions laid down in the Regulation.
- ← AI Office: The AI Office operates in compliance with the Regulation's requirements.
- ← European Data Protection Supervisor: The European Data Protection Supervisor has the power to impose fines under this Regulation.
- → Court of Justice of the European Union: Decisions taken under this Regulation are subject to review by the Court of Justice.
- ← Article 5 TEU: The Regulation is implemented in accordance with the principles outlined in Article 5 of the TEU.
- → 2 August 2030: Operators of certain AI systems must comply with the Regulation by this date.
- → 2 August 2026: The Regulation will be applicable from 2 August 2026, requiring compliance from high-risk AI systems after this date.
- → 2 February 2025: Prohibitions and general provisions of the Regulation should apply from this date due to unacceptable risks.
- → 2 August 2025: The governance and conformity assessment system for general-purpose AI models must be operational by 2 August 2025.
- → 2 May 2025: Codes of practice should be ready by this date.
- → Union: The regulation operates under the jurisdiction of the European Union.
- → Annex I: The regulation includes safeguards related to high-risk AI systems as outlined in Annex I.
- ← Member States: Member States retain competences that may affect the implementation of the regulation in relation to national security.
- ← Article 97: Article 97 allows the Commission to amend conditions laid down in the regulation based on evidence regarding AI systems.
- ← Article 96: Article 96 specifies guidelines for the practical implementation of the regulation concerning AI systems.
- ← Annex III: Annex III includes conditions that safeguard health, safety, and fundamental rights in relation to AI systems.
- → Article 7: The regulation includes Article 7, which outlines the conditions for amending Annex III.
- ← OJ L, 12.7.2024: The regulation was published in the official journal on this date.
- → Article 47: The regulation includes Article 47, which pertains to the EU declaration of conformity.
- → Article 11: The regulation includes Article 11, which pertains to the technical documentation.
- → Article 74(10): The regulation includes Article 74(10), which outlines the obligations of competent authorities.
- → Article 12(1): The regulation includes Article 12(1), which refers to the logs generated by the AI system.
- → Article 49(1): The regulation includes Article 49(1), which details registration obligations.
- ← high-risk AI systems: High-risk AI systems must have necessary documentation to comply with the regulation.
- → Article 16: Article 16 is a part of the regulation that outlines specific obligations for high-risk AI systems.
- ← notified bodies: Notified bodies operate in accordance with the requirements set out in the regulation.
- ← Article 34: Article 34 is part of the regulation that specifies operational obligations for notified bodies.
- ← Article 35: Article 35 is included in the regulation and discusses identification numbers for notified bodies.
- ← Article 36: Article 36 is part of the regulation and outlines the process for notifying changes to notified bodies.
- ← national competent authorities: National competent authorities ensure the application and implementation of the Regulation.
- ← Article 68(1): Article 68(1) refers to the implementing act that amends the structure and level of fees.
- ← national competent authorities: National competent authorities must operate under the guidelines set by the Regulation.
- ← national competent authorities: National competent authorities may provide guidance and advice on the implementation of the Regulation.
- ← market surveillance authority: The market surveillance authority operates under the guidelines set by the Regulation.
- ← Directive 2013/36/EU: The Regulation includes provisions that amend or relate to the Directive concerning financial institutions.
- ← Member State: Member States are required to establish rules regarding the imposition of administrative fines as per the regulation.
- ← Article 100: Article 100 is part of the broader regulation concerning administrative fines.
- → 2 August 2027: The Regulation requires compliance by this date for large-scale IT systems.
- → 31 December 2030: The Regulation sets this date as the final compliance deadline for large-scale IT systems.
- → 2 August 2030: Providers and deployers of high-risk AI systems must comply with the Regulation by this date.
- → AI Office: The Regulation lays down rules for the establishment and functioning of the AI Office.
- → market: The Regulation affects the market by regulating the entry of undertakings, particularly SMEs.
- ← AI Office: The AI Office is tasked with developing methodologies for evaluating risk levels based on the Regulation.
- → Annex III: The Regulation includes a list of AI systems in Annex III that may require additional scrutiny.
- → Article 50: Article 50 specifies additional transparency measures for certain AI systems.
- → 2 August 2031: The Commission must assess the enforcement of the Regulation by 2 August 2031.
Regulation (EC) No 2006/2004
This regulation, amended by Directive 2005/29/EC, addresses consumer protection cooperation and concerns unfair commercial practices.
- ← Directive 2005/29/EC: Directive 2005/29/EC amends Regulation (EC) No 2006/2004 concerning consumer protection.
- → Directive (EU) 2022/2557: Regulation (EC) No 2006/2004 includes provisions that relate to the directives on critical infrastructure.
Regulation (EC) No 300/2008
This regulation outlines rules and procedures related to security equipment and artificial intelligence systems in the context of civil aviation security.
- → Regulation (EU) 2024/1689: Regulation (EU) 2024/1689 amends Regulation (EC) No 300/2008 to include provisions for artificial intelligence systems.
- ← Article 102: Article 102 discusses amendments to Regulation (EC) No 300/2008.
- → Regulation (EC) No 2320/2002: Regulation (EC) No 300/2008 repeals Regulation (EC) No 2320/2002.
- → OJ L 97, 9.4.2008: Regulation (EC) No 300/2008 was published in OJ L 97 on 9.4.2008.
Regulation (EC) No 45/2001
A regulation concerning the protection of individuals with regard to the processing of personal data by Community institutions and bodies.
Regulation (EC) No 765/2008
This regulation sets out the requirements for accreditation and market surveillance related to product marketing, ensuring compliance with EU standards.
- → personal data: The regulation outlines requirements that affect the processing of personal data.
- → national accreditation body: Regulation (EC) No 765/2008 outlines the framework within which national accreditation bodies operate.
- → CE marking: Regulation (EC) No 765/2008 provides the principles governing the CE marking.
Regulation (EC) No 810/2009
A regulation established by the European Parliament outlining procedural requirements for migration, asylum, and border control management within the EU.
- ← AI systems: AI systems in migration and border control must comply with the procedural requirements set by Regulation (EC) No 810/2009.
- → Directive 2013/32/EU: The Regulation (EC) No 810/2009 lays down procedural requirements that are relevant to the Directive 2013/32/EU.
- → Union harmonisation legislation: Regulation (EC) No 810/2009 is part of the existing Union harmonisation legislation.
Regulation (EU) 2016/679
Also known as the General Data Protection Regulation (GDPR), this regulation governs the processing of personal data and privacy rights within the European Union.
- → biometric data: Regulation (EU) 2016/679 defines biometric data in Article 4, point (14).
- → biometric data: Regulation (EU) 2016/679 lays down rules for the processing of biometric data.
- → Article 9(1): Regulation (EU) 2016/679 includes Article 9(1) which prohibits processing of biometric data for non-law enforcement purposes.
- ← AI system: AI systems must process personal data in compliance with Regulation (EU) 2016/679 regarding data protection.
- → Article 4, point (4): Regulation (EU) 2016/679 includes safeguards related to profiling as defined in Article 4, point (4).
- → AI system: Regulation (EU) 2016/679 lays down rules for the assessment and registration of AI systems.
- ← Remote biometric identification systems: Remote biometric identification systems are classified as high-risk under the provisions of Regulation (EU) 2016/679.
- ← AI systems intended for biometric verification: These systems are excluded from high-risk classification under Regulation (EU) 2016/679.
- ← AI systems intended for biometric categorisation: These systems are regulated under Article 9(1) of Regulation (EU) 2016/679.
- ← data sets: Data governance practices for data sets must comply with the provisions of Regulation (EU) 2016/679.
- → personal data: The regulation establishes rules for the handling and protection of personal data.
- → personal data: This regulation includes safeguards for the processing of personal data.
- ← AI system: AI systems must provide documentation to demonstrate compliance with GDPR.
- ← post-remote biometric identification systems: The use of post-remote biometric identification systems is subject to the provisions of Regulation (EU) 2016/679.
- ← AI regulatory sandbox: The AI regulatory sandbox operates under the rules established by Regulation (EU) 2016/679.
- → personal data: This regulation affects the processing of personal data in relation to AI systems.
- → Directive (EU) 2016/680: Regulation (EU) 2016/679 amends provisions in Directive (EU) 2016/680 concerning data protection.
- ← Regulation (EU) 2018/1725: Regulation (EU) 2018/1725 amends Regulation (EU) 2016/679 to include provisions for EU institutions.
- → biometric data: The regulation includes safeguards for the processing of biometric data for purposes other than law enforcement.
- → real-time remote biometric identification systems: Regulation (EU) 2016/679 lays down rules for the processing of biometric data, which includes the use of remote identification systems.
- ← personal data: The processing of personal data must comply with Regulation (EU) 2016/679.
- ← high-risk AI system for post-remote biometric identification: The use of high-risk AI systems must comply with Regulation (EU) 2016/679 regarding personal data processing.
- → Article 35: Regulation (EU) 2016/679 includes Article 35, which pertains to data protection impact assessments.
- ← sandbox: The sandbox operates in accordance with the rules laid down in Regulation (EU) 2016/679 regarding personal data protection.
- → market surveillance authority: The Regulation includes safeguards for data protection that the market surveillance authority must enforce.
- → Market surveillance authorities: Lays down rules for the designation of market surveillance authorities.
- ← OJ L, 12.7.2024: The publication date indicates the regulation's amendments or updates related to AI systems.
- ← OJ L, 12.7.2024: The date of publication in the Official Journal for Regulation (EU) 2016/679.
- ← ELI: http://data.europa.eu/eli/reg/2024/1689/oj: The ELI link serves as technical documentation for Regulation (EU) 2016/679.
Regulation (EU) 2016/680
A regulation governing the processing of personal data for law enforcement purposes in the EU, particularly focusing on biometric data protection.
Regulation (EU) 2017/745
A regulation that establishes safety and performance requirements for medical devices, including those incorporating high-risk AI systems.
Regulation (EU) 2017/746
A regulation ensuring compliance with safety and performance requirements for in vitro diagnostic medical devices, relevant to high-risk AI systems.
- → Directive 2001/83/EC: Regulation (EU) 2017/746 amends Directive 2001/83/EC.
- ← high-risk AI systems: High-risk AI systems are classified and must comply with the criteria and safety component requirements set forth in Regulation (EU) 2017/746.
- → Directive 98/79/EC: Regulation (EU) 2017/746 repeals Directive 98/79/EC.
- → OJ L 117, 5.5.2017: Regulation (EU) 2017/746 was published in OJ L 117 on 5.5.2017.
Regulation (EU) 2018/1139
A regulation that is amended to include provisions regarding Artificial Intelligence systems as safety components.
- → Regulation (EU) 2024/1689: Regulation (EU) 2018/1139 is amended to incorporate requirements from Regulation (EU) 2024/1689.
Regulation (EU) 2018/1241
A regulation amending Regulation (EU) 2016/794 to establish the European Travel Information and Authorisation System (ETIAS).
Regulation (EU) 2018/1725
This regulation governs the protection of personal data processed by EU institutions and bodies, ensuring compliance with data protection standards.
- ← Regulation: The Regulation incorporates safeguards consistent with Regulation (EU) 2018/1725.
- → biometric data: Regulation (EU) 2018/1725 defines biometric data in Article 3, point (18).
- → biometric data: Regulation (EU) 2018/1725 includes safeguards for the processing of biometric data.
- → Article 10(1): Regulation (EU) 2018/1725 includes Article 10(1) which also prohibits certain processing of biometric data.
- ← AI system: AI systems must adhere to Regulation (EU) 2018/1725 concerning personal data processing by EU institutions.
- → Article 3, point (5): Regulation (EU) 2018/1725 includes specific provisions regarding personal data processing as defined in Article 3, point (5).
- → personal data: This regulation provides safeguards for the processing of personal data by EU institutions.
- ← AI system: AI systems must comply with the documentation requirements set forth in this regulation.
- ← EU Database: The EU database operates under the guidelines set by Regulation (EU) 2018/1725.
- ← AI regulatory sandbox: The AI regulatory sandbox operates under the rules established by Regulation (EU) 2018/1725.
- → European Data Protection Supervisor: The European Data Protection Supervisor was consulted in accordance with Article 42 of Regulation (EU) 2018/1725.
- → personal data: This regulation affects the processing of personal data by EU institutions.
- → Regulation (EU) 2016/679: Regulation (EU) 2018/1725 amends Regulation (EU) 2016/679 to include provisions for EU institutions.
- ← personal data: The processing of personal data must comply with Regulation (EU) 2018/1725.
- ← sandbox: The sandbox complies with the provisions of Regulation (EU) 2018/1725 concerning the processing of personal data.
Regulation (EU) 2018/1860
A regulation concerning the use of the Schengen Information System for the return of illegally staying third-country nationals.
Regulation (EU) 2018/858
A regulation regarding the approval and market surveillance of motor vehicles and their trailers.
Regulation (EU) 2019/1020
This regulation outlines the framework for market surveillance and compliance of products, including AI systems, within the EU, ensuring enforcement and oversight.
- → Union law: The regulation lays down rules that are complementary to existing Union law.
- → AI systems: The regulation addresses the impact of AI systems on consumers and other persons.
- → Directive on improving working conditions in platform work: The regulation should not affect provisions aimed at improving working conditions in platform work.
- ← Regulation: The Regulation amends and incorporates the provisions of Regulation (EU) 2019/1020 for market surveillance.
- → surveillance authorities: This regulation provides the framework for the enforcement powers of surveillance authorities.
- ← AI systems: AI systems may be regulated under this regulation if they present risks.
- ← high-risk AI systems: High-risk AI systems must adhere to specific documentation requirements as per the regulation.
- ← prohibited systems: Prohibited systems must comply with transparency requirements outlined in the regulation.
- ← Directive 2009/138/EC: Directive 2009/138/EC includes provisions that are enforced under Regulation (EU) 2019/1020.
- ← market surveillance authorities: Market surveillance authorities are guided by Article 9 of Regulation (EU) 2019/1020 for compliance activities.
- ← AI Office: The AI Office operates under the framework established by Regulation (EU) 2019/1020 to monitor AI systems.
- ← European Central Bank: The European Central Bank has specific tasks conferred by Regulation (EU) 2019/1020 regarding the supervision of credit institutions.
- → providers of general-purpose AI models: This regulation provides procedural rights that apply to providers of general-purpose AI models.
- ← market surveillance authority: Market surveillance authorities operate in accordance with Regulation (EU) 2019/1020 to ensure compliance.
- ← Board: The Board's activities are governed by Regulation (EU) 2019/1020.
- → Article 3: Regulation (EU) 2019/1020 includes Article 3, which defines and details serious incidents.
- → Annex III: Regulation (EU) 2019/1020 includes Annex III, which lists high-risk AI systems.
- → Article 20: Regulation (EU) 2019/1020 includes Article 20, which mandates notification of serious incidents.
- → Article 34(4): Regulation (EU) 2019/1020 includes Article 34(4), outlining reporting obligations for market surveillance authorities.
- → Union market: Regulation (EU) 2019/1020 applies to AI systems in the Union market.
- → market surveillance authority: Regulation (EU) 2019/1020 establishes the framework and rules for the operation of market surveillance authorities.
- → high-risk AI systems: Regulation that provides a framework for the oversight of high-risk AI systems.
- → Article 9: Article 9 is part of Regulation (EU) 2019/1020, which addresses high-risk AI systems.
- ← Market surveillance authorities: Market surveillance authorities require access to documentation as per the rules set in Regulation (EU) 2019/1020.
- → Chapter VI of Regulation (EU) 2019/1020: Regulation (EU) 2019/1020 includes provisions that amend the procedures in Chapter VI.
- ← Regulation (EU) 2024/1689: Regulation (EU) 2024/1689 amends the provisions related to market surveillance as outlined in Regulation (EU) 2019/1020.
- ← Article 79: Article 79 is part of Regulation (EU) 2019/1020, detailing procedures for AI systems presenting risks.
- → Member States: The regulation lays down rules that Member States must follow regarding the evaluation of AI systems.
- → Article 18 of Regulation (EU) 2019/1020: Regulation (EU) 2019/1020 includes Article 18 which applies to compliance measures.
- ← market surveillance authorities: Market surveillance authorities act in accordance with the provisions set out in Regulation (EU) 2019/1020.
- → Article 71: Regulation (EU) 2019/1020 includes safeguards related to the EU database mentioned in Article 71.
- → Commission: The Commission acts in accordance with the provisions set out in Regulation (EU) 2019/1020.
- → Article 85: Regulation (EU) 2019/1020 includes Article 85, which addresses the right to lodge complaints.
- → Article 86: Regulation (EU) 2019/1020 includes Article 86, which provides rights related to decision-making explanations.
- ← Article 94: Article 94 applies the provisions of Regulation (EU) 2019/1020 to providers of general-purpose AI models.
Regulation (EU) 2019/2144
A regulation addressing mandatory requirements for high-risk AI systems as safety components.
- → high-risk AI systems: This regulation establishes mandatory requirements for high-risk AI systems.
- ← Regulation (EU) 2018/858: Regulation (EU) 2018/858 is amended to ensure compliance with the requirements laid down in Regulation (EU) 2019/2144.
- → Article 11: Regulation (EU) 2019/2144 includes Article 11 which is amended.
- → Regulation (EU) 2024/1689: Regulation (EU) 2019/2144 is amended to include requirements from Regulation (EU) 2024/1689.
Regulation (EU) 2019/816
A regulation establishing a centralised system for identifying Member States holding conviction information on third-country nationals and stateless persons (ECRIS-TCN).
Regulation (EU) 2019/817
A regulation on establishing a framework for interoperability between EU information systems in the field of borders and visa.
- → EU information systems: Regulation (EU) 2019/817 lays down rules for interoperability between EU information systems.
- ← OJ L, 12.7.2024: A future publication date referenced in the context of Regulation (EU) 2019/817.
Regulation (EU) 2019/881
A regulation aimed at enhancing cybersecurity across the EU, establishing requirements for high-risk AI systems and cybersecurity certification.
- → ENISA: The regulation outlines the tasks assigned to ENISA regarding cybersecurity.
- → Regulation (EU) No 526/2013: Regulation (EU) 2019/881 repeals and amends the previous Cybersecurity Act.
- → 12.7.2024: The regulation is published in the Official Journal on this date.
- ← high-risk AI systems: High-risk AI systems must comply with the requirements set out in Regulation (EU) 2019/881.
- ← Article 54(3): Article 54(3) is a specific provision within Regulation (EU) 2019/881.
- → cybersecurity scheme: Regulation (EU) 2019/881 includes provisions for a cybersecurity scheme for high-risk AI systems.
Regulation (EU) 2022/2065
This regulation, established by the European Parliament and Council, outlines the liability and obligations of providers of intermediary services, particularly regarding AI systems, and amends Directive 2000/31/EC to enhance compliance and detection of illegal content.
- → intermediary services: Regulation (EU) 2022/2065 includes provisions regarding the liability of providers of intermediary services.
- → AI system: The regulation lays down rules regarding the definition and characteristics of AI systems.
- → Directive 2000/31/EC: Regulation (EU) 2022/2065 amends Directive 2000/31/EC.
- → OJ L: Regulation (EU) 2022/2065 was published in the Official Journal on 27.10.2022.
- ← AI systems: AI systems must comply with the obligations set forth in Regulation (EU) 2022/2065 regarding the detection and disclosure of content.
- ← very large online platforms: Very large online platforms are obliged to assess systemic risks as per the requirements of Regulation (EU) 2022/2065.
- ← very large online search engines: Very large online search engines must also comply with the obligations regarding systemic risks outlined in Regulation (EU) 2022/2065.
- ← AI models: AI models are regulated under the framework established by Regulation (EU) 2022/2065.
- → very large online platforms: The regulation lays down rules for the obligations of providers and deployers of very large online platforms regarding the detection and disclosure of artificially generated outputs.
- → very large online search engines: The regulation establishes obligations for very large online search engines to identify and mitigate risks from artificially generated content.
- ← Regulation (EU) No 1025/2012: Regulation (EU) No 1025/2012 provides the framework for harmonised standards that are referenced in Regulation (EU) 2022/2065.
- ← Article 2, point (1)(c): This article is part of Regulation (EU) No 1025/2012 and is relevant for demonstrating compliance with Regulation (EU) 2022/2065.
- ← very large online platforms: These platforms are required to document their processes for identifying and mitigating risks from AI-generated content as per the regulation.
- ← very large online search engines: Similar to platforms, these search engines must document their compliance with the regulation's obligations.
- → public interest: The regulation aims to improve public interest by ensuring transparency in AI-generated content.
- → Article 16(6): Regulation (EU) 2022/2065 includes Article 16(6) which outlines obligations for hosting service providers.
- → Article 16(1): Regulation (EU) 2022/2065 includes Article 16(1) which addresses the processing of notices on illegal content.
- ← Regulation (EU) 2024/1689: The regulation does not affect the provisions on liability set out in Regulation (EU) 2022/2065.
Regulation (EU) 2022/868
A regulation by the European Parliament and Council concerning the protection of personal data and amending Regulation (EU) 2018/1724.
- → personal data: This regulation lays down rules for the protection of personal data under Union law.
- → Data Governance Act: Regulation (EU) 2022/868 amends the Data Governance Act.
Regulation (EU) 2023/2854
A regulation by the European Parliament and Council addressing the transfer of personal data under Union law and harmonizing rules on data access and use.
- → personal data: This regulation establishes rules for the transfer of personal data under Union law.
- → Data Act: Regulation (EU) 2023/2854 amends the Data Act.
Regulation (EU) 2023/988
A regulation aimed at ensuring the safety of AI systems not classified as high-risk, serving as a safety net and amending previous regulations.
Regulation (EU) 2024/1689
A regulation establishing harmonized rules for high-risk AI systems, outlining compliance obligations, cooperation requirements, and confidentiality for national authorities.
- → high-risk AI systems: The regulation lays down rules applicable to high-risk AI systems.
- → competent authorities: The regulation requires cooperation with competent authorities for compliance.
- → AI systems: The regulation lays down rules for the application of AI systems in relation to national security.
- → Member States: The regulation affects the market by defining the scope of AI systems that Member States can regulate.
- → Regulation (EU) 2022/2065: The regulation does not affect the provisions on liability set out in Regulation (EU) 2022/2065.
- → international organisations: The regulation includes safeguards for international organisations using AI systems.
- → third country: The regulation outlines conditions under which AI systems from third countries may be used.
- → Article 78: Regulation (EU) 2024/1689 includes Article 78, which details confidentiality obligations.
- → Regulation (EU) 2019/1020: Regulation (EU) 2024/1689 amends the provisions related to market surveillance as outlined in Regulation (EU) 2019/1020.
- → Market Surveillance Authority: The regulation lays down rules for the operation of the market surveillance authority.
- → Article 77(1): The regulation includes Article 77(1) which details cooperation requirements.
- ← Regulation (EC) No 300/2008: Regulation (EU) 2024/1689 amends Regulation (EC) No 300/2008 to include provisions for artificial intelligence systems.
- → European Parliament: Regulation (EU) 2024/1689 is proposed by the European Parliament.
- → Court of Justice of the European Union: The Court of Justice reviews decisions made under Regulation (EU) 2024/1689.
- → Chapter III, Section 2: Regulation (EU) 2024/1689 includes specific safeguards and requirements outlined in Chapter III, Section 2.
- → 13 June 2024: Regulation (EU) 2024/1689 was adopted on June 13, 2024.
- → Regulation (EU) No 167/2013: Regulation (EU) 2024/1689 amends Regulation (EU) No 167/2013.
- → Artificial Intelligence Act: Regulation (EU) 2024/1689 is part of the Artificial Intelligence Act.
- ← Article 103: Article 103 is part of Regulation (EU) 2024/1689.
- → Directives 2014/90/EU, 2016/797, 2020/1828: Regulation (EU) 2024/1689 amends several directives including 2014/90/EU, 2016/797, and 2020/1828.
- → Regulation (EU) No 168/2013: Regulation (EU) 2024/1689 amends Regulation (EU) No 168/2013 by adding a new subparagraph.
- → 12.7.2024: The publication date of Regulation (EU) 2024/1689 in the Official Journal.
- ← Article 104: Article 104 of Regulation (EU) No 168/2013 acts in accordance with the requirements set out in Regulation (EU) 2024/1689.
- → European Parliament: Regulation (EU) 2024/1689 is enacted in accordance with the legislative processes of the European Parliament.
- ← Directive (EU) 2016/797: Directive (EU) 2016/797 is amended to include provisions related to AI systems as safety components under Regulation (EU) 2024/1689.
- → Artificial Intelligence Act: Regulation (EU) 2024/1689 is also known as the Artificial Intelligence Act.
- → Regulation (EU) 2018/858: Regulation (EU) 2024/1689 amends Regulation (EU) 2018/858.
- ← Regulation (EU) 2018/1139: Regulation (EU) 2018/1139 is amended to incorporate requirements from Regulation (EU) 2024/1689.
- → Article 17: Regulation (EU) 2024/1689 includes requirements that must be considered in Article 17 of Regulation (EU) 2018/1139.
- → Article 19: Regulation (EU) 2024/1689 includes requirements that must be considered in Article 19 of Regulation (EU) 2018/1139.
- → Article 43: Regulation (EU) 2024/1689 includes requirements that must be considered in Article 43 of Regulation (EU) 2018/1139.
- → Chapter III, Section 2: Chapter III, Section 2 of Regulation (EU) 2024/1689 outlines specific requirements for AI systems.
- ← Regulation (EU) 2019/2144: Regulation (EU) 2019/2144 is amended to include requirements from Regulation (EU) 2024/1689.
Regulation (EU) 2024/900
A regulation by the European Parliament and Council aimed at ensuring transparency and addressing risks of undue external interference in political advertising and voting rights.
- → Article 39 of the Charter: Regulation (EU) 2024/900 addresses risks related to the right to vote as enshrined in Article 39.
- ← AI systems: AI systems intended to influence elections are classified as high-risk under Regulation (EU) 2024/900.
- → Union harmonisation legislation: Regulation (EU) 2024/900 contributes to the body of Union harmonisation legislation.
Regulation (EU) No 1024/2013
A regulation that establishes the Single Supervisory Mechanism for financial institutions in the EU and mandates reporting to the European Central Bank.
- → European Central Bank: The regulation requires market surveillance authorities to report information regarding market surveillance activities to the European Central Bank.
- → Directive 2013/36/EU: The regulation aims to integrate procedural obligations related to risk management into the existing obligations under Directive 2013/36/EU.
Regulation (EU) No 1025/2012
This regulation outlines the framework for European standardisation, defining harmonised standards and ensuring stakeholder involvement for compliance with various regulations.
- → Regulation (EU) 2022/2065: Regulation (EU) No 1025/2012 provides the framework for harmonised standards that are referenced in Regulation (EU) 2022/2065.
- ← European Commission: The European Commission proposes the regulation to facilitate compliance with standardisation requirements.
- → European standardisation organisations: The regulation requires documentation from European standardisation organisations to ensure compliance.
- → common specifications: The regulation includes provisions for common specifications as a fallback when harmonised standards are inadequate.
- → Council Directives 89/686/EEC and 93/15/EEC: Regulation (EU) No 1025/2012 amends these Council Directives.
- → OJ L, 12.7.2024: The regulation is published in the Official Journal on this date.
- ← high-risk AI system: The high-risk AI system is presumed to comply with the measures set out in this regulation.
- ← Regulation (EU) 2023/988: Regulation (EU) 2023/988 amends Regulation (EU) No 1025/2012.
- ← harmonised standard: The harmonised standard is defined in Article 2(1) of Regulation (EU) No 1025/2012.
- ← common specification: The common specification is defined in Article 2 of Regulation (EU) No 1025/2012.
- → Article 40: Article 40 references Regulation (EU) No 1025/2012 for standardisation requests.
- ← European standardisation organisations: European standardisation organisations are required to act in accordance with the provisions of Regulation (EU) No 1025/2012.
- → Article 41: Regulation (EU) No 1025/2012 includes Article 41, which outlines common specifications.
- → European standardisation organisations: Regulation (EU) No 1025/2012 proposes that the Commission requests European standardisation organisations to draft harmonised standards.
- ← Article 41: Article 41 acts in accordance with the provisions set out in Regulation (EU) No 1025/2012.
- → Official Journal of the European Union: Regulation (EU) No 1025/2012 outlines the obligations that are published in the Official Journal.
- → Commission: The procedures outlined in Regulation (EU) No 1025/2012 may be applied by the Commission in response to justified national measures.
- → Article 11: Regulation (EU) No 1025/2012 includes Article 11, which outlines the procedure for evaluation.
Regulation (EU) No 167/2013
This regulation concerns the safety of certain components in the aviation sector and the approval and market surveillance of agricultural and forestry vehicles.
Regulation (EU) No 168/2013
A regulation concerning the approval and market surveillance of agricultural, forestry vehicles, and two- or three-wheel vehicles, including quadricycles.
Regulation (EU) No 182/2011
A regulation outlining procedures for the exercise of implementing powers conferred on the European Commission.
- ← Commission: The Commission exercises implementing powers in accordance with Regulation (EU) No 182/2011.
- → Commission: This regulation confers implementing powers on the Commission.
- → Member States: The regulation is designed to be exercised in accordance with Member States' control mechanisms.
- → Article 98: Regulation (EU) No 182/2011 includes Article 98 which outlines the committee procedure.
- → Article 99: Regulation (EU) No 182/2011 includes Article 99 which details penalties for infringements.
- ← Commission: The Commission issues guidelines pursuant to Regulation (EU) No 182/2011.
Regulation (EU) No 526/2013
The previous regulation that was repealed by Regulation (EU) 2019/881, known as the Cybersecurity Act.
Regulation (EU) No 575/2013
A regulation on prudential requirements for credit institutions and investment firms, amending Regulation (EU) No 648/2012.
- ← Union financial services law: The Union financial services law acts in accordance with Regulation (EU) No 575/2013.
- → Directive 2008/48/EC: Regulation (EU) No 575/2013 amends previous regulations and directives related to financial services.
Regulation 2024/1689
This regulation establishes a framework for the classification, management, and compliance of high-risk AI systems, including transparency and documentation requirements.
- → publicly accessible space: Regulation 2024/1689 defines the rules and characteristics of publicly accessible spaces.
- → OJ L, 12.7.2024: Regulation 2024/1689 was published in the official journal on July 12, 2024.
- → ELI: http://data.europa.eu/eli/reg/2024/1689/oj: Regulation 2024/1689 requires technical documentation for reference.
- → European Union: The regulation requires compliance from the European Union institutions and bodies.
- → Europol: Europol must ensure its operations comply with the stipulations of the regulation.
- → AI system: The regulation includes safeguards for the deployment of AI systems by Union institutions.
- ← 12.7.2024: The date of publication for Regulation 2024/1689 is July 12, 2024.
- ← OJ L: The regulation is published in the Official Journal of the European Union on the specified date.
- → Union harmonisation legislation: Regulation 2024/1689 lays down rules that complement the existing Union harmonisation legislation.
- → AI systems: Regulation 2024/1689 addresses the risks associated with AI systems in the market.
- → general-purpose AI model: The regulation lays down rules for the classification and management of general-purpose AI models that may present systemic risks.
- ← open-source model: The release of open-source models may complicate compliance with the obligations under Regulation 2024/1689.
- → AI systems: Regulation 2024/1689 lays down harmonized rules for the labeling of content generated by AI systems and their placement on the market in the Union.
- ← OJ L, 12.7.2024: Regulation 2024/1689 was published in the official journal on 12.7.2024.
- → 2 August 2025: Provisions on penalties in Regulation 2024/1689 will take effect from 2 August 2025.
- → SMEs: The regulation includes measures to support innovation, particularly focusing on SMEs.
- → Article 49(1): Regulation 2024/1689 includes Article 49(1) which outlines registration obligations.
- → Article 43: Regulation 2024/1689 includes Article 43 detailing conformity assessment procedures.
- → Article 11: Regulation 2024/1689 includes Article 11 which specifies technical documentation requirements.
- → Article 47: Regulation 2024/1689 includes Article 47 regarding the EU declaration of conformity.
- → Article 22(1): Regulation 2024/1689 includes Article 22(1) which mandates the appointment of an authorised representative.
- → EU declaration of conformity: Regulation 2024/1689 requires the EU declaration of conformity for compliance.
- → CE marking: Regulation 2024/1689 requires that the AI system bears the CE marking.
- ← high-risk AI system: High-risk AI systems must comply with the requirements set out in Regulation 2024/1689.
- → Article 25: Regulation 2024/1689 includes Article 25, which outlines responsibilities for high-risk AI systems.
- → Article 16: Regulation 2024/1689 includes Article 16, which specifies obligations for providers of high-risk AI systems.
- → Article 6: Regulation 2024/1689 includes Article 6, which defines the criteria for high-risk AI systems.
- → Official Journal of the European Union: Regulation 2024/1689 includes references to harmonised standards published in the Official Journal of the European Union.
- ← general-purpose AI models: General-purpose AI models must cooperate with the Commission and national authorities as per the regulation.
- → Article 56: Regulation 2024/1689 includes Article 56, which pertains to codes of practice for compliance.
- → Annex XI: Regulation 2024/1689 includes directives related to compliance as outlined in Annex XI.
- → Annex XII: The regulation empowers the Commission to amend Annex XII in response to technological developments.
- ← general-purpose AI model: The general-purpose AI model must comply with the obligations set forth in Regulation 2024/1689.
- ← AI Office: The AI Office is responsible for addressing issues related to compliance with Regulation 2024/1689.
- → Article 55: Regulation 2024/1689 includes Article 55, which details specific obligations for AI model providers.
- → AI Office: The regulation proposes the development of the AI Office to enhance AI capabilities.
- → European Artificial Intelligence Board: The regulation proposes the establishment of the European Artificial Intelligence Board.
- ← Article 63: Article 63 is part of Regulation 2024/1689 and discusses derogations for microenterprises.
- → Recommendation 2003/361/EC: The regulation acts in accordance with the guidelines set forth in Recommendation 2003/361/EC regarding microenterprises.
- ← Commission: The Commission acts in accordance with Regulation 2024/1689 to implement AI governance.
- ← Member States: Member States are involved in the implementation of Regulation 2024/1689.
- → Article 69: Regulation 2024/1689 includes Article 69, which outlines access to the pool of experts.
- → Article 74(11): Regulation 2024/1689 includes Article 74(11), which refers to cross-border market surveillance activities.
- → Article 88: Regulation 2024/1689 includes Article 88, which discusses enforcement obligations for AI model providers.
- ← AI Office: The AI Office acts in accordance with Regulation 2024/1689 to monitor compliance.
- ← Article 89: Article 89 is part of Regulation 2024/1689 and outlines monitoring actions.
- ← Article 90: Article 90 is part of Regulation 2024/1689 and discusses alerts of systemic risks.
- ← Commission: The Commission proposes amendments to Regulation 2024/1689 based on technological developments.
- → 2 August 2026: The regulation applies from this date.
- → 2 February 2025: Chapters I and II of the regulation apply from this date.
- → 2 August 2027: Article 6(1) and corresponding obligations apply from this date.
- ← R. Metsola: The President of the European Parliament signed the regulation.
- ← M. Michel: The President of the Council of the European Union signed the regulation.
- ← Directive 2006/42/EC: This directive amends previous legislation related to machinery.
- ← Directive 2009/48/EC: This directive amends previous legislation related to toy safety.
- ← High-risk AI systems: High-risk AI systems are regulated under Regulation 2024/1689.
Regulation on the ‘real-time’ use of AI systems
A regulation that lays down rules for the real-time use of AI systems, emphasizing the need for immediate processing without significant delays.
Regulations (EU) 2016/679
This regulation safeguards the fundamental right to personal data protection within the EU, outlining principles for data processing.
- ← Regulation: The Regulation includes safeguards that align with the provisions of Regulations (EU) 2016/679.
- → personal data: Sets rules for the processing of personal data to ensure protection and security.
Regulations (EU) 2018/1725
A regulation concerning the protection of personal data in the context of EU institutions and bodies.
- → personal data: Establishes rules for the processing of personal data by EU institutions.
reinforcement learning
A method of training AI models where they learn to make decisions by receiving rewards or penalties.
remote biometric identification
A method of identifying individuals in real-time using biometric data in publicly accessible spaces.
- → natural persons: This modality can intrusively identify natural persons, affecting their rights and freedoms.
remote biometric identification system
An AI system designed for the identification of individuals at a distance without their active involvement, using biometric data.
- → biometric data: The remote biometric identification system utilizes biometric data for the identification of individuals.
- ← Regulation: The Regulation establishes rules governing the use of remote biometric identification systems.
Remote biometric identification systems
AI systems used for identifying individuals based on biometric data, classified as high-risk due to potential discriminatory effects.
- → Regulation (EU) 2016/679: Remote biometric identification systems are classified as high-risk under the provisions of Regulation (EU) 2016/679.
right not to be discriminated against
A fundamental right that may be violated by AI systems that perpetuate historical patterns of discrimination.
right to education and training
A fundamental right that may be violated by improperly designed AI systems.
rightsholders
Individuals or entities that hold the rights to works and have the authority to grant or deny permissions for their use.
- → general-purpose AI models: Rightsholders require that providers of general-purpose AI models obtain authorization for text and data mining of their works.
risk analytics
Analytical processes used to assess the likelihood of certain events, such as financial fraud or the localization of illicit goods.
- ← AI systems: AI systems can use risk analytics that do not involve profiling individuals.
risk assessment
A process to evaluate the potential risks associated with a serious incident involving an AI system.
- ← provider: The investigation performed by the provider includes a risk assessment of the serious incident.
risk management system
A systematic process for identifying, evaluating, and managing risks associated with high-risk AI systems throughout their lifecycle.
- ← Article 9: Article 9 specifies the requirements for the risk management system that must be implemented for high-risk AI systems.
- → high-risk AI systems: The risk management system must be documented and maintained in relation to high-risk AI systems.
- → post-market monitoring system: The risk management system utilizes data from the post-market monitoring system to evaluate risks.
risk taxonomy
A classification system for identifying and categorizing systemic risks associated with AI at the Union level.
- → systemic risks: The risk taxonomy includes safeguards for identifying and categorizing systemic risks at the Union level.
risk-management policies
Policies aimed at identifying and mitigating risks associated with AI models.
risk-management system
A systematic approach for identifying, assessing, and mitigating risks associated with high-risk AI systems throughout their lifecycle to ensure compliance and effectiveness.
- → high-risk AI system: The risk-management system aims to improve the safety and compliance of high-risk AI systems.
- ← provider: The provider must document and explain the choices made in the risk-management system.
- → AI systems: The risk-management system aims to improve the safety and effectiveness of AI systems.
robustness
Robustness refers to the ability of an AI system to perform reliably under a variety of conditions and to withstand errors or unexpected inputs.
- ← AI regulatory sandboxes: AI regulatory sandboxes evaluate the robustness of AI systems to ensure they can handle various operational conditions.
safeguards
Measures that ensure the rights and freedoms of third parties are maintained when using AI-generated content.
- → transparency obligation: Safeguards are included in the transparency obligation to protect third-party rights.
- ← high-risk AI system: The high-risk AI system includes safeguards to protect personal data during processing.
safeguards
Measures implemented to protect the fundamental rights and freedoms of natural persons when processing personal data.
- → transparency obligation: Safeguards are included in the transparency obligation to protect third-party rights.
- ← high-risk AI system: The high-risk AI system includes safeguards to protect personal data during processing.
safety components
Systems used to protect the physical integrity of critical infrastructure and the health and safety of persons and property.
sandbox
A controlled environment where data can be processed under specific conditions to test AI systems while ensuring data protection.
- → Regulation (EU) 2016/679: The sandbox operates in accordance with the rules laid down in Regulation (EU) 2016/679 regarding personal data protection.
- → Regulation (EU) 2018/1725: The sandbox complies with the provisions of Regulation (EU) 2018/1725 concerning the processing of personal data.
- → personal data: The sandbox requires documentation to ensure that personal data is processed in a secure and compliant manner.
sandbox plan
A document that describes the objectives and conditions for activities within an AI regulatory sandbox.
- → AI regulatory sandbox: The sandbox plan outlines the conditions and requirements for activities in the AI regulatory sandbox.
scientific panel
The scientific panel is a group of independent experts that provides insights, alerts, and support for the enforcement of AI regulations, particularly regarding systemic risks associated with general-purpose AI models.
- ← AI Office: The AI Office receives alerts and opinions from the scientific panel regarding AI models.
- ← Member States: Member States can request support from the scientific panel for enforcement activities.
- → AI Office: The scientific panel advises and supports the AI Office in monitoring activities and enforcing the Regulation.
- → general-purpose AI models: The scientific panel can assess risks associated with general-purpose AI models.
- ← Commission: The Commission proposes the establishment of a scientific panel to support enforcement activities.
- → Article 68: The scientific panel is established in accordance with Article 68 of the regulation.
- → Article 98(2): The scientific panel's establishment follows the examination procedure outlined in Article 98(2).
- ← Commission: The Commission selects experts for the scientific panel based on their expertise in AI.
- → general-purpose AI models: The scientific panel provides advice on the classification and evaluation of general-purpose AI models.
- → benchmarks: The scientific panel contributes to the development of benchmarks for evaluating AI models.
- ← Member States: Member States may call upon experts from the scientific panel to support their enforcement activities under the Regulation.
- → AI Office: The scientific panel may request assistance from the AI Office for the performance of its tasks.
- ← Article 84: Union AI testing support acts in accordance with the scientific panel's recommendations.
- → AI Office: The scientific panel transmits alerts regarding systemic risks to the AI Office.
- → general-purpose AI model: The scientific panel may issue a request for information regarding the general-purpose AI model.
- ← Article 90: Article 90 allows the scientific panel to provide opinions regarding systemic risks of AI models.
scientific research and development
Activities focused on the advancement of knowledge and technology, which may involve AI systems and models.
- ← Regulation: The Regulation does not apply to AI systems developed solely for scientific research and development.
Section 2
A section of the regulation detailing specific requirements for conformity and high-risk AI systems.
- ← high-risk AI system: High-risk AI systems must comply with the requirements set out in Section 2.
- ← Notified Bodies: Notified bodies must have the necessary competences to evaluate tasks related to the requirements set out in Section 2.
- ← Article 40: Article 40 acts in accordance with the requirements set out in Section 2 of the regulation.
- ← high-risk AI system: Section 2 outlines specific requirements that high-risk AI systems must adhere to.
Section 2
A section within the regulation that outlines specific requirements for AI systems and data.
- ← high-risk AI system: High-risk AI systems must comply with the requirements set out in Section 2.
- ← Notified Bodies: Notified bodies must have the necessary competences to evaluate tasks related to the requirements set out in Section 2.
- ← Article 40: Article 40 acts in accordance with the requirements set out in Section 2 of the regulation.
- ← high-risk AI system: Section 2 outlines specific requirements that high-risk AI systems must adhere to.
Section 3
A section that outlines the obligations of the provider and deployer of high-risk AI systems.
- ← High-risk AI systems: High-risk AI systems must be accompanied by instructions for use as outlined in Section 3.
Section A of Annex I
Section A of Annex I lists the Union harmonisation legislation relevant to high-risk AI systems.
- ← high-risk AI system: High-risk AI systems are related to products covered by the Union harmonisation legislation listed in Section A of Annex I.
Section A of Annex I
A section that lists Union harmonisation legislation applicable to high-risk AI systems.
- ← high-risk AI system: High-risk AI systems are related to products covered by the Union harmonisation legislation listed in Section A of Annex I.
sectoral group of notified bodies
A group formed to ensure coordination and cooperation among notified bodies.
- ← notified body: Notified bodies are required to participate in the sectoral group to ensure best practices.
self-supervised learning
A method of training AI models where the model learns from the data without explicit labels.
self-supervision
A training method used in AI models that allows them to learn from large amounts of data without explicit supervision.
- ← large generative AI models: Large generative AI models utilize self-supervision to learn from vast datasets, enhancing their capabilities.
sensitive operational data
Operational data related to criminal activities that, if disclosed, could compromise ongoing investigations.
- ← high-risk AI system: The obligation to inform the Commission does not cover sensitive operational data related to law-enforcement activities.
serious incident
An event involving an AI system that results in significant consequences or risks, necessitating immediate reporting.
- ← law enforcement: Law enforcement activities may be influenced by serious incidents involving AI systems.
- → personal data: Serious incidents can lead to infringements of obligations under Union law protecting personal data.
- → 15 days: Providers must report serious incidents within 15 days of awareness.
- ← provider: The provider is required to report serious incidents related to AI systems.
- ← deployer: The deployer must report serious incidents when they become aware of them.
serious incident
An incident or malfunctioning of an AI system that leads to significant harm or disruption.
- ← law enforcement: Law enforcement activities may be influenced by serious incidents involving AI systems.
- → personal data: Serious incidents can lead to infringements of obligations under Union law protecting personal data.
- → 15 days: Providers must report serious incidents within 15 days of awareness.
- ← provider: The provider is required to report serious incidents related to AI systems.
- ← deployer: The deployer must report serious incidents when they become aware of them.
significant harm
The potential negative impact that AI systems can have on individuals or groups, which may occur even without intent.
small and microenterprises
Small and micro-sized businesses that may have different documentation requirements under the regulations.
- ← Commission: Proposes a simplified technical documentation form for small and microenterprises.
SMEs
Small and medium-sized enterprises (SMEs) are vital to the economy and innovation, benefiting from simplified compliance requirements and targeted support under Union law, while being encouraged to participate in AI regulatory sandboxes.
- → Union copyright law: Union copyright law includes provisions that allow simplified compliance for SMEs.
- ← AI regulatory sandbox: The AI regulatory sandbox aims to enhance accessibility for SMEs to foster innovation.
- ← Member States: Member States propose initiatives targeted at SMEs to support their development and innovation.
- → start-ups: SMEs include start-ups as part of their category for support and initiatives.
- → standardisation development processes: SMEs should facilitate participation in standardisation development processes.
- ← Member States: Member States should facilitate the participation of SMEs in standardisation development processes.
- ← Commission Recommendation 2003/361/EC: The regulation defines the criteria that affect the classification and support of SMEs.
- ← Regulation 2024/1689: The regulation includes measures to support innovation, particularly focusing on SMEs.
- ← AI regulatory sandboxes: AI regulatory sandboxes include safeguards to ensure free access for SMEs, including start-ups.
- ← AI regulatory sandboxes: AI regulatory sandboxes facilitate the participation of SMEs by simplifying application and administrative processes.
- ← Article 62: Article 62 specifically addresses measures for providers and deployers, including small and medium-sized enterprises (SMEs).
- ← AI regulatory sandboxes: The establishment of AI regulatory sandboxes is intended to benefit SMEs by providing them with priority access.
- ← Article 43: Article 43 requires that fees for conformity assessment be adjusted based on the size and market of SMEs.
- ← AI Office: The AI Office considers the specific interests and needs of SMEs when developing codes of conduct.
- ← Article 99: Article 99 takes into account the interests of SMEs when determining penalties.
SMEs
Small and Medium-sized Enterprises (SMEs) are businesses with personnel below certain limits, playing a crucial role in the economy and innovation, and are prioritized for access to AI regulatory sandboxes and compliance considerations.
- → Union copyright law: Union copyright law includes provisions that allow simplified compliance for SMEs.
- ← AI regulatory sandbox: The AI regulatory sandbox aims to enhance accessibility for SMEs to foster innovation.
- ← Member States: Member States propose initiatives targeted at SMEs to support their development and innovation.
- → start-ups: SMEs include start-ups as part of their category for support and initiatives.
- → standardisation development processes: SMEs should facilitate participation in standardisation development processes.
- ← Member States: Member States should facilitate the participation of SMEs in standardisation development processes.
- ← Commission Recommendation 2003/361/EC: The regulation defines the criteria that affect the classification and support of SMEs.
- ← Regulation 2024/1689: The regulation includes measures to support innovation, particularly focusing on SMEs.
- ← AI regulatory sandboxes: AI regulatory sandboxes include safeguards to ensure free access for SMEs, including start-ups.
- ← AI regulatory sandboxes: AI regulatory sandboxes facilitate the participation of SMEs by simplifying application and administrative processes.
- ← Article 62: Article 62 specifically addresses measures for providers and deployers, including small and medium-sized enterprises (SMEs).
- ← AI regulatory sandboxes: The establishment of AI regulatory sandboxes is intended to benefit SMEs by providing them with priority access.
- ← Article 43: Article 43 requires that fees for conformity assessment be adjusted based on the size and market of SMEs.
- ← AI Office: The AI Office considers the specific interests and needs of SMEs when developing codes of conduct.
- ← Article 99: Article 99 takes into account the interests of SMEs when determining penalties.
social behaviour
Data related to the actions and interactions of individuals within a society, used for evaluation by AI systems.
- → social score: Social behavior data is used to calculate the social score of individuals.
social score
A metric derived from the evaluation of individuals' social behavior, which can lead to favorable or unfavorable treatment.
- ← social behaviour: Social behavior data is used to calculate the social score of individuals.
social scoring
A practice where individuals are scored based on their behavior or characteristics, potentially leading to discriminatory outcomes.
- → AI system: Social scoring by AI systems may lead to discriminatory outcomes, affecting market dynamics and inclusion.
Software Packages
Different forms in which the AI system is made available, including embedded software and downloadable packages.
- ← AI System: The AI system is available in various software package forms.
specific high-risk AI systems
Particular AI systems identified as high-risk that may be authorized for market placement under exceptional circumstances.
- ← Member State: Member States may propose the authorization of specific high-risk AI systems for market placement under exceptional circumstances.
- ← law-enforcement authorities: Law-enforcement authorities may act in accordance with regulations to put specific high-risk AI systems into service without prior authorization in urgent situations.
stakeholders
Stakeholders include various entities such as industry, academia, civil society, and standardization organizations involved in the development and design of AI practices.
- → ethical principles: Stakeholders are encouraged to take ethical principles into account when developing AI practices.
- → AI systems: Stakeholders are involved in ensuring that AI systems are developed with safeguards for inclusivity and accessibility.
standardisation development processes
Processes aimed at creating standards for AI systems, in which SMEs and other stakeholders should participate.
- ← SMEs: SMEs should facilitate participation in standardisation development processes.
start-ups
Newly established businesses classified as SMEs that are involved in the development and deployment of AI systems, considered in compliance and standardization contexts.
- ← SMEs: SMEs include start-ups as part of their category for support and initiatives.
- ← Member States: Member States should take into account the specific interests of start-ups when setting conformity assessment fees.
- ← codes of conduct: Codes of conduct may also consider the needs of start-ups in their development.
subject
A natural person who participates in testing in real-world conditions.
- → informed consent: A subject must provide informed consent to participate in testing.
substantial modification
A change to an AI system after its market placement that affects compliance with initial assessment requirements.
- → AI system: Substantial modifications affect the compliance of AI systems with initial assessment requirements.
synthetic content
Content generated by AI systems that can be difficult to distinguish from human-generated content.
- ← AI systems: AI systems generate synthetic content that is hard to distinguish from authentic content.
synthetic data generation
A method used to enhance the capabilities of AI models by creating artificial data for training purposes.
- ← general-purpose AI model: Synthetic data generation is one of the methods used to improve the capabilities of general-purpose AI models.
system architecture
The structure of software components and their interactions within an AI system.
systemic risk
A risk associated with high-impact capabilities of AI models that can significantly affect the Union market and public welfare.
systemic risks
Systemic risks associated with AI arise from the capabilities of general-purpose AI models, potentially leading to widespread negative impacts at the Union level.
- ← general-purpose AI model: General-purpose AI models are evaluated against parameters related to their associated systemic risks due to their high-impact capabilities.
- ← codes of practice: Codes of practice aim to improve the management and assessment of systemic risks associated with AI.
- ← risk taxonomy: The risk taxonomy includes safeguards for identifying and categorizing systemic risks at the Union level.
- → codes of practice: The assessment and management of systemic risks must be documented as part of the codes of practice.
systemic risks
Risks that arise from the use of AI models that can have widespread implications for society.
- ← general-purpose AI model: General-purpose AI models are evaluated against parameters related to their associated systemic risks due to their high-impact capabilities.
- ← codes of practice: Codes of practice aim to improve the management and assessment of systemic risks associated with AI.
- ← risk taxonomy: The risk taxonomy includes safeguards for identifying and categorizing systemic risks at the Union level.
- → codes of practice: The assessment and management of systemic risks must be documented as part of the codes of practice.
technical documentation
Comprehensive documentation detailing the characteristics, capabilities, limitations, and compliance of AI systems, essential for regulatory assessment.
- ← Regulation: The Regulation requires the maintenance of technical documentation for high-risk AI systems.
- → general-purpose AI models: Providers of general-purpose AI models are required to complement technical documentation with information on modifications.
- ← AI system: AI systems must have technical documentation detailing their intended use, training, testing, and validation processes.
- ← high-risk AI systems: High-risk AI systems require technical documentation to demonstrate compliance prior to market placement.
- → Annex IV: The technical documentation must include elements specified in Annex IV to ensure compliance.
- ← high-risk AI system: The high-risk AI system requires technical documentation to be made available to authorities.
- ← provider: The provider must submit technical documentation for assessment by the notified body.
- ← notified body: The notified body examines the technical documentation of the AI system.
- → Article 53(1): The technical documentation must comply with the requirements laid out in Article 53(1).
- → general-purpose AI model: Technical documentation is required for the integration of the general-purpose AI model into AI systems.
- ← Article 53(1): Article 53(1) specifies the requirements for the technical documentation.
technical limitations
Measures that restrict the re-use of personal data to ensure compliance with privacy and security standards.
- ← high-risk AI system: The high-risk AI system requires documentation of technical limitations on the re-use of personal data.
technical redundancy solutions
Strategies implemented to ensure the robustness of high-risk AI systems, including backup or fail-safe plans.
- ← High-risk AI systems: High-risk AI systems incorporate technical redundancy solutions to enhance their robustness.
technical solutions
Solutions that providers of AI systems must ensure are effective, interoperable, robust, and reliable.
- → AI systems: Technical solutions aim to improve the effectiveness and reliability of AI systems.
testing and experimentation facilities
Facilities established by the Commission and Member States to support the testing and experimentation of new technologies in compliance with regulations.
- → this Regulation: These facilities support the testing of technologies in line with the Regulation's objectives.
- → Regulation: These facilities contribute to the implementation of the Regulation.
- ← Commission: The Commission facilitates access to testing and experimentation facilities for accredited bodies.
testing data sets
Testing data sets assess the accuracy and reliability of AI models before deployment and may be accessed for evaluation.
- → high-risk AI system: Testing data sets must be documented to ensure they meet the governance and management practices for high-risk AI systems.
- ← notified body: The notified body is granted access to the testing data sets for conformity assessment.
testing in real-world conditions
The temporary testing of an AI system in real-world conditions to gather reliable data and assess conformity with regulatory requirements.
- → AI systems: Defines the process for testing AI systems in real-world conditions.
- ← Article 57: Article 57 outlines specific conditions for testing in real-world conditions.
- ← Article 60: Article 60 provides additional conditions for testing in real-world conditions.
TEU
The Treaty on European Union (TEU) establishes the constitutional framework and principles guiding the European Union.
- ← Protocol No 22: Protocol No 22 is annexed to the TEU, outlining Denmark's position regarding EU regulations.
text and data mining
Techniques used for the retrieval and analysis of content, which may involve copyright protected material.
TFEU
The Treaty on the Functioning of the European Union (TFEU) outlines the operational framework and institutional functions of the EU.
- → Article 16 TFEU: Article 16 is a part of the TFEU that deals with personal data protection.
TFEU
The Treaty on the Functioning of the European Union (TFEU) outlines the functioning of the European Union and its institutions.
- → Article 16 TFEU: Article 16 is a part of the TFEU that deals with personal data protection.
The 'Blue Guide' on the implementation of EU product rules 2022
A Commission notice providing guidance on the implementation of EU product rules and clarifying the application of Union harmonization legislation.
- ← New Legislative Framework: The New Legislative Framework is clarified by the 'Blue Guide' document.
- → Union law: The Blue Guide provides guidance that aligns with Union law regarding product compliance and safety.
third country
A country that is not a member of the European Union.
- ← Member States: Member States may establish bilateral agreements with third countries for law enforcement and judicial cooperation.
- ← Europol: Europol may cooperate with third countries under established agreements for law enforcement purposes.
- ← Regulation (EU) 2024/1689: The regulation outlines conditions under which AI systems from third countries may be used.
third party
An external entity that supplies AI systems, tools, services, components, or processes used in high-risk AI systems.
- → high-risk AI systems: Third parties must provide necessary information and assistance to comply with obligations regarding high-risk AI systems.
third-party conformity assessment body
An independent organization that evaluates products to ensure they meet regulatory standards.
threshold of floating point operations
A set limit that, if met by a general-purpose AI model, indicates potential systemic risks associated with that model.
- ← general-purpose AI model: The general-purpose AI model is assessed based on whether it meets the threshold of floating point operations.
toys
Products intended for play, which may be classified as high-risk under certain regulations.
trade secrets
Information that is not generally known or reasonably ascertainable, which must be protected under the law.
- ← high-risk AI systems: The deployment of high-risk AI systems must include safeguards for trade secrets.
training data
Data used for training an AI system by fitting its learnable parameters.
- → AI system: Training data is a data set used for training AI systems.
training data set
The collection of data used to train the AI model, which is a criterion for assessing systemic risks.
- → general-purpose AI model: The training data set is a parameter that influences the assessment of the general-purpose AI model's risks.
training data sets
Training data sets for AI models must meet specific quality criteria and governance practices, and may be accessed for conformity assessment.
- → high-risk AI system: Training data sets must be documented to ensure they meet the governance and management practices for high-risk AI systems.
- ← personal data: Training data sets that include personal data must have safeguards in place to protect individuals' rights and privacy.
- ← notified body: The notified body is granted access to the training data sets for conformity assessment.
training data sources
Data collections or sets used to train AI models, which must be disclosed by providers under Union law.
- → general-purpose AI models: Training data sources are a type of data set that must be disclosed by providers of general-purpose AI models.
training, validation and testing data sets
Data sets used for training, validating, and testing AI models to ensure they meet quality criteria.
- ← High-risk AI systems: High-risk AI systems are developed using training, validation, and testing data sets that meet specific quality criteria.
- ← Data and data governance: The article on data governance includes safeguards regarding the quality of data sets used for AI systems.
transparency
The quality of being clear and open about how AI systems operate, which is crucial for accountability and public trust.
- ← AI systems: AI systems should be transparent to ensure accountability and public trust.
transparency obligation
A requirement for AI system providers to disclose when content has been artificially created or manipulated.
- → deep fakes: The transparency obligation aims to improve the disclosure of AI-generated content to maintain authenticity.
- ← Charter: The transparency obligation must align with the rights guaranteed in the Charter.
- ← safeguards: Safeguards are included in the transparency obligation to protect third-party rights.
transparency requirements
Requirements that mandate high-risk AI systems to provide clear and understandable information to users and deployers.
- ← high-risk AI systems: High-risk AI systems must include transparency requirements to ensure users understand their functionality.
Treaties
Legal agreements that form the basis of the European Union's legal framework.
- → Charter: The Treaties provide the legal basis for the Charter of Fundamental Rights.
Treaty on European Union (TEU)
A foundational treaty of the European Union that outlines its values and principles.
- ← AI: AI development should align with the values enshrined in the Treaty on European Union.
UN Convention relating to the Status of Refugees
An international treaty that defines the rights of refugees and the responsibilities of nations to protect them.
- ← AI systems: AI systems in migration and asylum must comply with the obligations set by the UN Convention relating to the Status of Refugees.
Union
Refers to the European Union, the governing body responsible for establishing regulations and standards for AI systems across member states.
- ← Regulation: The Regulation applies to providers and deployers of AI systems within the Union.
- ← AI system: AI systems used in third countries can affect the market in the Union by processing data and providing outputs.
- ← Regulation: The regulation operates under the jurisdiction of the European Union.
- ← AI Office: The AI Office reports its assessments and findings to the Union regarding the codes of practice.
- → National competent authorities: The regulations set by the Union affect the operations and responsibilities of national competent authorities.
- ← provider or prospective provider: Providers must be established in the Union or appoint a legal representative in the Union.
- → AI Office: The AI Office serves all operators across the Union, providing information related to AI regulation.
Union AI testing support structures
Designated entities by the Commission to perform tasks related to AI testing and provide technical or scientific advice.
- → Article 21(6): The Union AI testing support structures perform tasks as outlined in Article 21(6) of Regulation (EU) 2019/1020.
Union and national law
Legal frameworks that govern the lawful evaluation practices of natural persons.
- → natural persons: These laws govern the lawful evaluation practices of natural persons, ensuring their rights are protected.
Union and National Liability Law
Legal framework under which providers or prospective providers are liable for damages caused during testing in real-world conditions.
- → AI System: The liability law affects the market by holding providers accountable for damages during testing.
Union anti-money laundering law
Legislation aimed at preventing money laundering activities within the European Union.
- → AI systems: AI systems used for administrative tasks by tax and customs authorities are excluded from high-risk classification.
Union copyright law
The body of law governing copyright within the European Union, affecting the obligations of AI model providers.
- ← general-purpose AI models: General-purpose AI models must comply with Union copyright law regarding the use of training data.
- ← SMEs: Union copyright law includes provisions that allow simplified compliance for SMEs.
Union data protection law
Legislation that outlines principles for data minimization and protection by design and by default.
- → personal data: This law applies principles of data protection to the processing of personal data.
Union ethical guidelines for trustworthy AI
A set of principles established by the Union to ensure that AI systems are developed and used in a trustworthy manner.
- ← codes of conduct: Codes of conduct may incorporate elements from the Union ethical guidelines for trustworthy AI.
Union financial services law
A set of regulations governing financial institutions within the EU, focusing on internal governance, risk management, and quality management requirements.
- → Regulation (EU) No 575/2013: The Union financial services law acts in accordance with Regulation (EU) No 575/2013.
- → Directive 2008/48/EC: The Union financial services law acts in accordance with Directive 2008/48/EC.
- ← high-risk AI systems: High-risk AI systems must comply with the obligations and regulations established in Union financial services law.
- → harmonised standards: Union financial services law includes provisions for harmonised standards relevant to quality management.
- ← providers that are financial institutions: Providers that are financial institutions must act in accordance with Union financial services law regarding documentation.
- → deployer: The Union financial services law sets requirements for the internal governance of financial institutions acting as deployers.
- ← deployers of high-risk AI systems: Deployers must adhere to the rules set forth in Union financial services law regarding internal governance.
Union harmonisation legislation
Legislation designed to facilitate the free movement of products within the EU while ensuring consistent safety and compliance standards.
- → AI systems: The legislation establishes rules to ensure that AI systems do not compromise safety and compliance in the market.
- ← third-party conformity assessment body: Third-party conformity assessment bodies evaluate products according to Union harmonisation legislation.
- → machinery: Union harmonisation legislation affects the classification and safety standards of machinery.
- → toys: Union harmonisation legislation affects the classification and safety standards of toys.
- → medical devices: Union harmonisation legislation affects the classification and safety standards of medical devices.
- → in vitro diagnostic medical devices: Union harmonisation legislation affects the classification and safety standards of in vitro diagnostic medical devices.
- ← Regulation 2024/1689: Regulation 2024/1689 lays down rules that complement the existing Union harmonisation legislation.
- ← Regulation (EC) No 810/2009: Regulation (EC) No 810/2009 is part of the existing Union harmonisation legislation.
- ← Directive 2013/32/EU: Directive 2013/32/EU is also part of the existing Union harmonisation legislation.
- ← Regulation (EU) 2024/900: Regulation (EU) 2024/900 contributes to the body of Union harmonisation legislation.
- ← conformity assessment: The conformity assessment for high-risk AI systems should align with existing Union harmonisation legislation.
- ← AI system: AI systems must comply with the requirements of Union harmonisation legislation.
- → high-risk AI systems: Union harmonisation legislation impacts the market for high-risk AI systems by establishing compliance standards.
- ← post-market monitoring plan: The post-market monitoring plan is developed in accordance with the Union harmonisation legislation.
- ← market surveillance authority: The market surveillance authority operates under the guidelines set by the Union harmonisation legislation.
Union harmonisation legislation
A body of legislation aimed at harmonising laws across the EU to ensure safety and health standards.
- → AI systems: The legislation establishes rules to ensure that AI systems do not compromise safety and compliance in the market.
- ← third-party conformity assessment body: Third-party conformity assessment bodies evaluate products according to Union harmonisation legislation.
- → machinery: Union harmonisation legislation affects the classification and safety standards of machinery.
- → toys: Union harmonisation legislation affects the classification and safety standards of toys.
- → medical devices: Union harmonisation legislation affects the classification and safety standards of medical devices.
- → in vitro diagnostic medical devices: Union harmonisation legislation affects the classification and safety standards of in vitro diagnostic medical devices.
- ← Regulation 2024/1689: Regulation 2024/1689 lays down rules that complement the existing Union harmonisation legislation.
- ← Regulation (EC) No 810/2009: Regulation (EC) No 810/2009 is part of the existing Union harmonisation legislation.
- ← Directive 2013/32/EU: Directive 2013/32/EU is also part of the existing Union harmonisation legislation.
- ← Regulation (EU) 2024/900: Regulation (EU) 2024/900 contributes to the body of Union harmonisation legislation.
- ← conformity assessment: The conformity assessment for high-risk AI systems should align with existing Union harmonisation legislation.
- ← AI system: AI systems must comply with the requirements of Union harmonisation legislation.
- → high-risk AI systems: Union harmonisation legislation impacts the market for high-risk AI systems by establishing compliance standards.
- ← post-market monitoring plan: The post-market monitoring plan is developed in accordance with the Union harmonisation legislation.
- ← market surveillance authority: The market surveillance authority operates under the guidelines set by the Union harmonisation legislation.
Union harmonised legislation
Legislation that sets out requirements applicable to various sectors, including those related to AI systems.
- ← high-risk AI system: High-risk AI systems must comply with the requirements set out in Union harmonised legislation.
- ← New Legislative Framework: The New Legislative Framework amends and provides structure to Union harmonised legislation.
Union institution, body, office or agency
Various entities within the European Union that are subject to regulations and oversight by the European Data Protection Supervisor.
Union institutions
Various bodies, offices, and agencies within the European Union that support law enforcement authorities.
Union institutions, agencies and bodies
Entities within the EU that are subject to specific regulations and oversight.
Union institutions, bodies, offices or agencies
Entities within the European Union that support governance, law enforcement, and may utilize high-risk AI systems.
Union law
Union law encompasses the body of laws and regulations governing the European Union, including those related to data protection and consumer rights.
- ← Regulation (EU) 2019/1020: The regulation lays down rules that are complementary to existing Union law.
- → Council Directive 85/374/EEC: Union law includes safeguards for consumers that remain unaffected by the new regulation.
- ← AI systems: AI systems must comply with Union law, including data protection and non-discrimination laws.
- → AI systems: Union law includes safeguards to protect individuals from the intrusive nature of AI systems.
- ← AI systems for credit evaluation: AI systems for credit evaluation are governed by Union law regarding their classification as high-risk.
- ← AI systems for health and life insurance: AI systems for health and life insurance are also subject to Union law, which addresses their potential risks.
- ← Emergency response AI systems: Emergency response AI systems are classified under Union law as high-risk due to their critical functions.
- ← New Legislative Framework: The New Legislative Framework clarifies that multiple acts of Union harmonization legislation may apply to a single product.
- ← The 'Blue Guide' on the implementation of EU product rules 2022: The Blue Guide provides guidance that aligns with Union law regarding product compliance and safety.
- ← high-risk AI system: High-risk AI systems must ensure compliance with Union law to prevent discrimination.
- ← high-risk AI systems: High-risk AI systems must comply with Union law and regulations.
- ← AI regulatory sandbox: The AI regulatory sandbox operates to ensure compliance with Union law.
- ← national competent authorities: National competent authorities supervise the application of Union law protecting fundamental rights.
- → AI systems: Union law lays down rules for the development and deployment of AI systems.
- ← AI system: The deployment of AI systems must comply with existing Union law that provides measures for redress and risk minimization.
- ← High-risk AI systems: Providers of high-risk AI systems must adhere to internal risk management processes and provide necessary documentation as required by Union law.
- ← Commission: The Commission evaluates authorizations based on compliance with Union law.
- ← general-purpose AI models: Providers must comply with Union law regarding copyright and related rights.
- ← Directive (EU) 2019/790: Directive (EU) 2019/790 amends existing Union law on copyright.
- → personal data: Union law includes safeguards for the processing of personal data, ensuring compliance with data protection standards.
- ← data collected: Data collected for testing must comply with appropriate safeguards under Union law.
- ← Article 78: Article 78 requires compliance with Union law regarding confidentiality.
Union law
A comprehensive body of laws within the European Union that governs various areas including data protection, non-discrimination, and the use of AI systems, ensuring compatibility across member states.
- ← Regulation (EU) 2019/1020: The regulation lays down rules that are complementary to existing Union law.
- → Council Directive 85/374/EEC: Union law includes safeguards for consumers that remain unaffected by the new regulation.
- ← AI systems: AI systems must comply with Union law, including data protection and non-discrimination laws.
- → AI systems: Union law includes safeguards to protect individuals from the intrusive nature of AI systems.
- ← AI systems for credit evaluation: AI systems for credit evaluation are governed by Union law regarding their classification as high-risk.
- ← AI systems for health and life insurance: AI systems for health and life insurance are also subject to Union law, which addresses their potential risks.
- ← Emergency response AI systems: Emergency response AI systems are classified under Union law as high-risk due to their critical functions.
- ← New Legislative Framework: The New Legislative Framework clarifies that multiple acts of Union harmonization legislation may apply to a single product.
- ← The 'Blue Guide' on the implementation of EU product rules 2022: The Blue Guide provides guidance that aligns with Union law regarding product compliance and safety.
- ← high-risk AI system: High-risk AI systems must ensure compliance with Union law to prevent discrimination.
- ← high-risk AI systems: High-risk AI systems must comply with Union law and regulations.
- ← AI regulatory sandbox: The AI regulatory sandbox operates to ensure compliance with Union law.
- ← national competent authorities: National competent authorities supervise the application of Union law protecting fundamental rights.
- → AI systems: Union law lays down rules for the development and deployment of AI systems.
- ← AI system: The deployment of AI systems must comply with existing Union law that provides measures for redress and risk minimization.
- ← High-risk AI systems: Providers of high-risk AI systems must adhere to internal risk management processes and provide necessary documentation as required by Union law.
- ← Commission: The Commission evaluates authorizations based on compliance with Union law.
- ← general-purpose AI models: Providers must comply with Union law regarding copyright and related rights.
- ← Directive (EU) 2019/790: Directive (EU) 2019/790 amends existing Union law on copyright.
- → personal data: Union law includes safeguards for the processing of personal data, ensuring compliance with data protection standards.
- ← data collected: Data collected for testing must comply with appropriate safeguards under Union law.
- ← Article 78: Article 78 requires compliance with Union law regarding confidentiality.
Union law on the protection of personal data
A legal framework established by the European Union to protect personal data and privacy.
- → personal data: Union law establishes rules for the protection and processing of personal data.
Union legal framework
A legal framework established by the EU to regulate AI systems and ensure public interest protection.
- → high-risk AI systems: The Union legal framework establishes rules for the development and use of high-risk AI systems.
- → public interests: The framework aims to improve the protection of public interests such as health and safety.
Union market
The economic area within the European Union where AI systems, particularly high-risk models, are regulated, monitored, and made available for use.
- ← high-risk AI systems: High-risk AI systems should only be placed on the Union market if they meet mandatory requirements.
- ← general-purpose AI models: General-purpose AI models must comply with copyright regulations to be placed on the Union market.
- ← general-purpose AI model: General-purpose AI models can be placed on the Union market.
- ← authorised representative: The authorised representative must ensure that the high-risk AI systems are compliant before they are made available on the Union market.
- ← high-risk AI systems: High-risk AI systems placed on the Union market must meet specific regulatory requirements.
- ← AI regulatory sandboxes: The establishment of AI regulatory sandboxes aims to facilitate and accelerate access to the Union market for AI systems.
- ← Regulation (EU) 2019/1020: Regulation (EU) 2019/1020 applies to AI systems in the Union market.
Union or national law
These legal frameworks govern the processing of personal data and may exempt certain high-risk AI systems from verification requirements, with potential fines for infringements.
- → high-risk AI systems: Union or national law may amend the requirements for verification of high-risk AI systems in specific contexts.
- ← AI regulatory sandboxes: The processing of personal data in AI regulatory sandboxes is based on specific Union or national laws.
- ← operator: Operators must comply with Union or national law to avoid infringements and fines.
Union safeguard procedure
A procedure that outlines the steps to be taken when objections are raised regarding measures taken by market surveillance authorities.
- → market surveillance authority: The Union safeguard procedure involves consultation with the market surveillance authority.
- → Member State: The Union safeguard procedure proposes actions to be taken when objections are raised by a Member State.
Union technical documentation assessment certificate
A certificate issued by a notified body indicating that an AI system conforms to required standards and assesses its technical documentation.
- ← notified body: The notified body issues a Union technical documentation assessment certificate if the AI system meets conformity requirements.
- ← AI system: The AI system must conform to requirements to receive the assessment certificate.
- → notified body: The notified body issues the Union technical documentation assessment certificate.
Union technical documentation assessment certificates
Certificates issued by the Union to confirm that technical documentation related to AI systems meets required standards.
- ← notified body: Notified bodies issue and manage Union technical documentation assessment certificates.
Union values
Principles that uphold respect for human dignity, freedom, equality, democracy, and fundamental rights, including non-discrimination and data protection.
- → AI system: AI systems that contradict Union values, such as manipulative practices, should be prohibited.
- ← Charter: The Charter includes fundamental rights that are part of the Union values.
Union-wide unique single identification number
A unique identifier assigned to each testing scenario in accordance with regulatory requirements, ensuring traceability and accountability.
- ← Article 61: Article 61 requires documentation of a unique identification number for testing scenarios.
Union’s Ethics Guidelines for Trustworthy AI
Guidelines aimed at ensuring ethical standards in the development and deployment of AI systems.
- → AI systems: The guidelines lay down rules for the ethical development and deployment of AI systems.
United Nations Convention on the Rights of Persons with Disabilities
An international treaty aimed at protecting the rights and dignity of persons with disabilities.
- → high-risk AI system: The convention aims to ensure that AI systems are designed to be accessible to persons with disabilities.
unsupervised learning
A method of training AI models that involves learning patterns from unlabelled data.
urgent situations
Situations where immediate action is required, allowing exceptions to the usual authorization process for biometric identification.
User Interface
The interface provided to the deployer for interacting with the AI system.
- ← AI System: The AI system includes a user interface for interaction.
users
Individuals or entities that deploy or interact with AI systems, who must be aware of the risks and instructions for use.
- → high-risk AI systems: The deployment of high-risk AI systems by users can significantly affect the market dynamics.
validation and testing procedures
Procedures used to validate and test the performance and compliance of AI systems.
- → AI system: The validation and testing procedures lay down rules for the performance and compliance of the AI system.
validation data
Data used for evaluating an AI system.
- → AI system: Validation data is a data set used for evaluating AI systems.
validation data sets
Validation data sets ensure AI models function correctly and meet intended purposes, and may be accessed for performance validation.
- → high-risk AI system: Validation data sets must be documented to ensure they meet the governance and management practices for high-risk AI systems.
- ← notified body: The notified body is granted access to the validation data sets for conformity assessment.
very large online search engines
Very large online search engines must comply with regulations concerning AI systems and manage risks from AI-generated or manipulated content.
- → Regulation (EU) 2022/2065: Very large online search engines must also comply with the obligations regarding systemic risks outlined in Regulation (EU) 2022/2065.
- ← Regulation (EU) 2022/2065: The regulation establishes obligations for very large online search engines to identify and mitigate risks from artificially generated content.
- → Regulation (EU) 2022/2065: Similar to platforms, these search engines must document their compliance with the regulation's obligations.
very large online search engines
AI systems that provide search functionalities on a large scale and are required to identify and mitigate systemic risks associated with artificially generated content.
- → Regulation (EU) 2022/2065: Very large online search engines must also comply with the obligations regarding systemic risks outlined in Regulation (EU) 2022/2065.
- ← Regulation (EU) 2022/2065: The regulation establishes obligations for very large online search engines to identify and mitigate risks from artificially generated content.
- → Regulation (EU) 2022/2065: Similar to platforms, these search engines must document their compliance with the regulation's obligations.
virtual reality
An immersive technology that can present stimuli to users, potentially distorting their behavior.
vulnerable groups
Specific populations at risk of discrimination or bias, including those affected by age or disability, requiring additional safeguards in AI interactions.
- ← data sets: Data sets should include safeguards to protect vulnerable groups from bias and discrimination.
- ← natural persons: Natural persons include vulnerable groups that require special consideration in AI interactions.
- ← Regulation: The Regulation includes safeguards for vulnerable groups during AI system testing.
- ← testing in real world conditions: Testing must ensure appropriate protection for vulnerable groups.
- ← market surveillance authority: The market surveillance authority must pay particular attention to vulnerable groups during evaluations.
vulnerable persons
Individuals or groups who may be negatively impacted by AI systems, including those with disabilities and issues related to gender equality.
- ← codes of conduct: Codes of conduct aim to assess and prevent the negative impact of AI systems on vulnerable persons.
vulnerable position
A state in which individuals or groups are at a disadvantage compared to the deployer of an AI system, often due to various socio-economic factors.
- → AI system: Individuals in a vulnerable position may be disproportionately affected by the outcomes produced by AI systems.
watermarks
Techniques used to mark content in a machine-readable format to indicate its origin.
- ← AI systems: AI systems are required to embed technical solutions like watermarks to indicate content origin.
widespread infringement
Acts or omissions contrary to Union law that harm the collective interests of individuals.
- ← deep fake: Deep fakes can lead to widespread infringement of laws protecting individual interests.
workers’ rights
Rights that may be impacted by AI systems used in employment and management.
World Trade Organization Agreement on Technical Barriers to Trade
An agreement aimed at facilitating international trade by reducing technical barriers.
- → Commission: The agreement encourages the Commission to facilitate mutual recognition of conformity assessments.